Acupuncture and assisted reproductive technology

  • Review
  • Intervention

Authors


Abstract

Background

Acupuncture is commonly undertaken during an assisted reproductive technology (ART) cycle although its role in improving live birth and pregnancy rates is unclear.

Objectives

To determine the effectiveness and safety of acupuncture as an adjunct to ART cycles for male and female subfertility.

Search methods

All reports which described randomised controlled trials of acupuncture in assisted conception were obtained through searches of the Menstrual Disorders and Subfertility Group Specialised Register, CENTRAL, Ovid MEDLINE, EMBASE, CINAHL (Cumulative Index to Nursing & Allied Health Literature), AMED , www.clinicaltrials.gov (all from inception to July 2013), National Research Register, and the Chinese clinical trial database (all to November 2012).

Selection criteria

Randomised controlled trials of acupuncture for couples who were undergoing ART, comparing acupuncture treatment alone or acupuncture with concurrent ART versus no treatment, placebo or sham acupuncture plus ART for the treatment of primary and secondary infertility. Women with medical illness that was deemed to contraindicate ART or acupuncture were excluded.

Data collection and analysis

Twenty randomised controlled trials were included in the review and nine were excluded. Study selection, quality assessment and data extraction were performed independently by two review authors. Meta-analysis was performed using odds ratio (OR) and 95% confidence intervals (CI). The outcome measures were live birth rate, clinical ongoing pregnancy rate, miscarriage rate, and any reported side effects of treatment. The quality of the evidence for the primary outcome (live birth) was rated using GRADE methods.

Main results

This updated meta-analysis showed no evidence of overall benefit of acupuncture for improving live birth rate (LBR) regardless of whether acupuncture was performed around the time of oocyte retrieval (OR 0.87, 95% CI 0.59 to 1.29, 2 studies, n = 464, I2 = 0%, low quality evidence) or around the day of embryo transfer (ET) (OR 1.22, 95% CI 0.87 to 1.70, 8 studies, n = 2505, I2 = 69%, low quality evidence). There was no evidence that acupuncture had any effect on pregnancy or miscarriage rates, or had significant side effects.

Authors' conclusions

There is no evidence that acupuncture improves live birth or pregnancy rates in assisted conception.

摘要

背景

針刺與輔助受孕

近來針刺已經被研究用來輔助生殖 (assisted reproductive treatment, ART) ,但其角色在生殖醫學上仍受到爭論

目標

來決定針刺對ART結果的有效性。

搜尋策略

所有描述用針刺來輔助受孕的隨機對照試驗的研究報告,都是經由搜尋以下資料庫:Menstrual Disorders and Subfertility Group Specialised Register, CENTRAL, Ovid MEDLINE (1996 to August 2007), EMBASE (1980 to August 2007), CINAHL (Cumulative Index to Nursing & Allied Health Literature) (1982 to August 2007), AMED, National Research Register, Clinical Trials register (www.clinicaltrials.gov), 與中國臨床試驗資料庫.

選擇標準

運用針刺的隨機對照實驗來比較:受試者接受ART與單獨使用針刺治療,或針刺合併ART組與安慰劑組、偽針刺合併ART組對於治療原發性或次發性不孕的效果。婦女有內科疾病被評定為不適合ART或是針刺者,則與以排除。

資料收集與分析

找到16個針刺與輔助受孕相關的隨機對照試驗,其中13個試驗被納入本文獻回顧,3個被排除。品質的評估與資料的選取由兩位複審作者個別執行。執行統合分析時二分結果是以odds ratio (OR) 來表示。結果檢測包括:活產率、臨床懷孕率、流產率、及治療副作用的報告。

主要結論

有證據顯示,在胚胎植入(embryo transfer, ET)當天施行針刺有助於活產率 (OR 1.89, 95% CI 1.29 to 2.77) ,但並不是在植入後兩至三天 (OR 1.79, 95% CI 0.93 to 3.44) 。沒有證據顯示於取卵時給予針刺治療有助於懷孕的結果。

作者結論

在胚胎植入的當天施行針刺,顯示對於活產率有助益的效果; 然而,依目前的證據這可能歸因於安慰劑效應,而且試驗的婦女數量太少。在臨床常規試驗中,針刺不可用於黃體期,除非有足夠充分的隨機對照試驗 (RCTs) 進一步的證據顯示可以使用

翻譯人

本摘要由高雄醫學大學附設醫院林宏隆翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

針刺與輔助受孕:從本統合分析的資料建議在胚胎植入當天施行針刺,有助於提高體外受孕 (in vitro fertilization, IVF) 治療的活產率。然而,這有可能歸因於安慰的效果,而且分析的試驗數太少,因此需要更大的研究來確定此結果。由於針刺對於懷孕早期有潛在的傷害,因此建議臨床醫師對於懷孕早期使用針刺應該要十分小心。

Résumé scientifique

Acupuncture et technique de procréation assistée

Contexte


L'acupuncture a été étudiée récemment dans le traitement de procréation assistée (TPA), bien que son rôle dans la médecine de la reproduction reste discuté.

Objectifs

Déterminer l'efficacité de l'acupuncture dans les critères de jugement de la TPA.

Stratégie de recherche documentaire

Tous les rapports qui décrivent des essais contrôlés randomisés de l'acupuncture dans la procréation assistée ont été obtenus par des recherches dans le registre spécialisé du groupe Cochrane sur les troubles menstruels et de la fertilité, CENTRAL, Ovid MEDLINE (de 1996 à août 2007), EMBASE (de 1980 à août 2007), CINAHL (Cumulative Index to Nursing & Allied Health Literature) (de 1982 à août 2007), AMED, le National Research Register, le Clinical Trials register (www.clinicaltrials.gov) et la Chinese database of clinical trials.

Critères de sélection

Les essais contrôlés randomisés portant sur l'acupuncture pour les couples qui subissaient une TPA et comparant le traitement par acupuncture seul ou l'acupuncture avec une TPA concomitante versus l'absence de traitement, un placebo ou une acupuncture simulée plus TPA pour le traitement de l'infertilité primaire et secondaire. Les femmes souffrant d'une affection médicale considérée comme une contre-indication pour la TPA ou l'acupuncture ont été exclues.

Recueil et analyse des données

Seize essais contrôlés randomisés portant sur l'acupuncture et la procréation assistée ont été identifiés. Treize essais ont été inclus dans la revue et trois ont été exclus. L’évaluation de la qualité et l’extraction des données ont été effectuées de façon indépendante par deux auteurs de la revue. La méta-analyse a été réalisée en utilisant le rapport de cotes (RC) pour les critères de jugement dichotomiques. Les critères de jugement étaient le taux de naissances vivantes, le taux de grossesses cliniques en cours et les effets secondaires rapportés du traitement.

Résultats principaux

Il y a des preuves d'un bénéfice lorsque l'acupuncture est pratiquée le jour du transfert d'embryons (TE) concernant le taux de naissances vivantes (RC 1,86, IC à 95 % 1,29 à 2,77), mais non lorsqu'elle est pratiquée deux à trois jours après le TE (RC 1,79, IC à 95 % 0,93 à 3,44). Il n'y a pas de preuves d'un bénéfice concernant les critères de jugement de grossesse lorsque l'acupuncture est pratiquée aux environs du moment du prélèvement d'ovocytes.

Conclusions des auteurs

L'acupuncture pratiquée le jour du TE montre un effet bénéfique sur le taux de naissances vivantes, cependant, d'après ces preuves, cela pourrait être attribué à l'effet placebo et au faible nombre de femmes incluses dans les essais. L'acupuncture ne doit pas être proposée durant la phase lutéale dans la pratique clinique courante avant que des preuves supplémentaires issues d'ECR d'une puissance suffisante soient disponibles.

초록

보조 생식 기술과 병행한 침 치료

배경

침 치료는 보조 생식 기술 적용 중 자주 활용된다. 그러나 생아 출생 및 임신률 향상에 대한 침 치료의 역할은 불분명하다.

목적

남성 및 여성 불임 환자에게 보조 생식 기술 적용 중 병행한 침 치료의 효과와 안전성을 평가함.

검색 전략

데이터베이스 9개 (월경곤란 및 불임 그룹의 Specialised Register, CENTRAL, Ovid MEDLINE, EMBASE, CINAHL, AMED, www.clinicaltrials.gov) (2013년 7월까지 검색) , National Research Register, Chinese clinical trial database (2012년 11월까지 검색) 에서, 보조 생식 기술 적용 시 침 치료에 대한 무작위 대조 연구를 검색하였다.

선정 기준

원발성 혹은 속발성 불임 치료 목적으로 보조 생식 기술을 받고 있는 남녀에 대한 침 치료 무작위 대조 연구가 분석 대상이며, 치료군은 침 치료만 받거나 보조 생식기술과 침 치료를 병행한다. 대조군은 보조 생식 기술에 거짓 침, 플라시보 침 치료를 받거나 어떠한 병행 치료도 받지 않는다. 보조 생식 기술 혹은 침 치료의 금기사항에 해당하는 질환을 가진 여성이 포함된 연구는 분석에서 배제하였다.

자료 수집 및 분석

20개 무작위 대조 연구가 리뷰에 포함되었다. 두 명의 저자가 각각 독립적으로 연구 선정, 질 평가, 자료 추출을 수행하였다. 메타-분석에는 오즈비 (OR) 와 95% 신뢰구간을 사용하였다. 평가 도구로, 생존 출생률, 임신 지속률, 임상적 임신률, 유산률, 치료 중 발생한 모든 이상 반응을 사용하였다. 주 평가 변수인 생존 출생률에 대해, GRADE 방법을 이용한 근거의 질 평가를 수행하였다.

주요 결과

이 업데이트된 메타-분석에서는, 침 치료가 난자 추출 시점 혹은 배아 이식일 시점에 시행되었건 간에 생존 출생률을 향상시키는데 효과적이라는 근거를 찾을 수 없었다. (난자 추출 시점 침 치료 효과: OR 0.87, 95% CI 0.59 ~ 1.29, 2개 연구, 464명, I2 = 0%, 근거의 질 낮음) (배아 이식일 시점 침 치료 효과: OR 1.22, 95% 신뢰구간 0.87 ~ 1.70, 8개 연구, 2505명, I2 = 69%, 근거의 질 낮음) 침 치료가 임신률 및 유산률에 영향을 주거나, 뚜렷한 이상반응을 나타내었다는 근거는 없었다.

연구진 결론

보조 생식 기술과 병행한 침 치료가 생존 출생률 혹은 임신률을 향상시킨다는 근거는 없다.

역주

이 리뷰는 김건형 님 (부산대학교 한의학전문대학원) 이 번역하였습니다. 번역 내용과 관련한 문의점은 pdchrist@gmail.com 으로 연락주세요.

アブストラクト

鍼療法と生殖補助技術

背景

鍼療法は一般的に生殖補助技術(ART)サイクルの中で行われているが、生児出生率および妊娠率の向上における役割については明らかではない。

目的

不妊症ではないが妊娠しにくい(subfertility) 男女におけるARTサイクルの補助として、鍼療法の有効性および安全性を検討すること。

検索戦略

妊娠を補助した鍼療法のランダム化比較試験についての全報告を、Menstrual Disorders and Subfertility Group Specialised Register、CENTRAL、Ovid MEDLINE、EMBASE、CINAHL (Cumulative Index to Nursing & Allied Health Literature)、AMED 、www.clinicaltrials.gov (開始から 2013年7月まですべて)、National Research Register、Chinese clinical trial database (2012年11月まですべて)の検索により入手した。

選択基準

原発性不妊症および続発性不妊症の治療として、鍼療法のみまたは鍼療法+ARTの併用治療と、無治療、プラセボ、偽鍼療法+ARTとを比較するARTを行っているカップルに対する鍼療法のランダム化比較試験。ARTまたは鍼療法が禁忌とされる内科的疾患のある女性は除外した。

データ収集と分析

レビューには20件のランダム化比較試験を対象とし、9件を除外した。研究の選択、品質評価およびデータ抽出は2名のレビュー著者により独立して行われた。メタアナリシスはオッズ比(OR)および95%信頼区間(CI)を用いて行われた。アウトカム指標は、生児出生率、臨床継続妊娠率、流産率、治療中報告された全副作用症例とした。GRADE法を用いて、主要アウトカム(生児出生率)のエビデンスの質を評価した。

主な結果

更新されたメタアナリシスでは、鍼療法における生児出生率(LBR)改善の総合的な利益のエビデンスは、卵母細胞の回収時(OR 0.87、95% CI 0.59〜1.29、2 件の試験、n = 464、I2 = 0%、エビデンスの質は低い)および、胚移植(ET)時(OR 1.22、95% CI 0.87〜1.70、8件の試験、n = 2505、I2 = 69%、エビデンスの質は低い)では認められなかった。 鍼療法が妊娠率および流産率への効果のエビデンスは認められず、鍼療法の有意な副作用も認められなかった。

著者の結論

鍼療法が妊娠の補助として生児出生率および妊娠率を改善するエビデンスは認められない。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.2]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Acupuncture and assisted conception

Review question: does acupuncture improve the outcomes of assisted reproduction?

Background: one in seven couples suffer from subfertility and many will seek help in the form of assisted reproductive technology (ART). Although the use of acupuncture has gained popularity, the use of this traditional Chinese medical treatment in conjunction with ART treatments is still controversial. This review summarised the evidence from well designed studies and evaluated the effectiveness and safety of acupuncture in assisted conception.

Search date: the evidence is current to July 2013.

Study characteristics: there were 20 randomised controlled studies identified. Six studies compared acupuncture at the time of egg collection (912 women) and 14 studies compared acupuncture in assisted conception (3632 women). The studies were further divided into those which used placebo needles in their control groups versus those that had controls who did not undergo any treatment. All the studies identified involved participants undertaking in vitro fertilization (IVF); there were no studies reporting the effect of acupuncture in ovulation induction or intrauterine insemination.

Funding of included studies: no included studies had external funding.

Key results: there is no evidence of benefit for the use of acupuncture in participants undergoing assisted conception treatment around the time of embryo transfer or at egg collection in terms of improving the live birth rate, ongoing or clinical pregnancy rate. There is also no evidence that acupuncture has any effect on miscarriage rate or had significant side effects.

Quality of the evidence: overall, the results are not similar across the studies. This was due to different study designs including the use of different types of control groups that could have introduced bias. More research is needed before recommendations can be made, including studies in which some controls receive placebo needling and others receive no intervention.

Résumé simplifié

Acupuncture et procréation assistée

Les données de cette méta-analyse suggèrent que l'acupuncture augmente effectivement le taux de naissances vivantes avec le traitement de fécondation in vitro (FIV) lorsqu'elle est pratiquée aux alentours du moment du transfert d'embryons. Cependant, cela pourrait être attribué à l'effet placebo et au faible nombre d'essais inclus dans la revue. Des études plus vastes devront être réalisées pour confirmer ces résultats. L'acupuncture peut avoir des effets nocifs potentiels au début de la grossesse ; les cliniciens doivent donc se montrer prudents lorsqu'ils donnent des conseils concernant l'utilisation de l'acupuncture pendant cette période.

Notes de traduction

Traduit par: French Cochrane Centre 19th February, 2013
Traduction financée par: Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux;

쉬운 말 요약

보조 생식 기술과 병행한 침 치료

연구 질문: 침 치료는 보조 생식 기술의 효과를 향상시키는가?

배경: 남녀 7쌍 중 1쌍은 불임으로 고통받고 있으며, 상당수가 보조 생식 기술을 받게 된다. 비록 침 치료가 널리 활용되어 왔지만, 보조 생식 기술과 병행한 전통 중의학적 침 치료의 활용은 아직 논란 중이다. 이 리뷰는 양질의 연구들을 취합하여 근거를 분석하였으며, 보조 생식 기술과 병행한 침 치료의 효과와 안전성을 평가하였다.

검색 일자: 이 근거는 2013년 7월까지의 연구자료를 바탕으로 하였다.

연구 특성: 20개의 무작위 대조 연구를 분석하였다. 6개 연구 (912명 여성) 는 난자 추출 시 침 치료를 병행하였고, 14개 연구 (3,632명 여성) 는 보조 생식 시 침 치료를 병행하였다. 분석을 위해 이 연구들을 거짓 침을 대조군으로 한 경우와, 아무런 병행치료를 하지 않은 경우로 세분하였다. 모든 연구들에서, 참여자들이 시험관 시술을 받았음을 확인하였다. 침 치료가 배란 유도에 효과가 있거나, 자궁 내 인공수정에 효과가 있었음을 보고한 연구는 없었다.

분석 대상 연구들에 대한 자금 지원: 어떤 연구도 외부 자금 지원을 받지 않았다.

핵심 결과: 생존 출생률, 임신 지속률, 임상적 임신률의 향상 측면에서, 배아 이식 또는 난자 추출 시점에 병행한 침 치료가 효과적이라는 근거는 없었다. 침 치료가 유산률에 영향을 주거나 뚜렷한 부작용과 연관성이 있다는 근거 역시 없었다.

근거의 질: 전반적으로, 각 연구들의 결과는 일치하지 않았다. 이는 연구 설계의 차이 때문으로 보이며, 특히 대조군의 유형이 서로 달랐다는 점이 분석 결과에 바이어스를 유발했을 수도 있다. 보조 생식 기술과 병행한 침 치료에 대한 권고를 내리기 전에 보다 많은 연구가 필요하며, 특히 거짓 침 대조군 및 아무런 치료를 받지 않는 무처치 대조군을 포함한 연구가 필요하다.

역주

이 리뷰는 김건형 님 (부산대학교 한의학전문대학원) 이 번역하였습니다. 번역 내용과 관련한 문의점은 pdchrist@gmail.com 으로 연락주세요.

平易な要約

鍼療法と妊娠補助

レビューの論点: 鍼療法は生殖補助としてアウトカムを改善するか。

背景:7組に1組のカップルが、妊娠しにくい状態(subfertility)に悩まされており、多くは生殖補助技術(ART)の助けを求めている。鍼療法の利用は普及しているが、この伝統的な中医学の治療をARTと併用することの是非をめぐって見解が分かれている。本レビューはよくデザインされた研究によるエビデンスを要約し、妊娠補助における鍼療法の有効性と安全性を評価した。

検索日:エビデンスは現在から2013年7月までである。

研究の特徴:20件のランダム化比較試験が同定された。6件の試験が採卵時(女性912例)における鍼療法を比較し、14件の試験が受胎補助(女性3632例)における鍼療法を比較した。研究は更に、対照群がプラセボ鍼を使用した研究と対照群が無治療の研究とに分けられた。同定されたすべての研究は体外受精(IVF)を行った参加者を対象とした。排卵誘発または子宮腔内授精に対する鍼療法の効果を報告した研究はなかった。

対象とした研究の資金提供:対象とした研究に外部からの資金提供を受けた研究はなかった。

主要な結果:胚移植時または採卵時の生児出生率、継続妊娠率、臨床的妊娠率の改善に関して、妊娠補助治療を行った参加者における鍼療法に、利益のエビデンスは認められなかった。鍼療法は、流産率における効果のエビデンスは認められず、有意な副作用も見られなかった。

エビデンスの質:全体的に、各研究は同様の結果ではなかった。これは様々な種類の対照群を用いるなど、異なる研究デザインであったため、バイアスが発生した可能性がある。鍼療法を奨めるにあたっては、対照がプラセボ鍼を受けるものや、介入を受けないものなどの研究を行い、更なる調査が必要である。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.2]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Laički sažetak

Akupunktura i medicinski potpomognuta oplodnja

Istraživačko pitanje: može li akupunktura poboljšati rezultate medicinski potpomognute oplodnje?

Dosadašnje spoznaje: jedan od sedam parova ima problema s neplodnosti i mnogi od njih traže pomoć u metodama medicinski potpomognute oplodnje (MPO). Iako je primjena akupunkture sve popularnija, primjena tog tradicionalnog kineskog liječenja u kombinaciji s metodama medicinski potpomognute oplodnje još uvijek je kontroverzna. Ovaj Cochrane sustavni pregled sažima podatke iz pouzdanih istraživanja i procjenu učinkovitosti i sigurnosti akupunkture u primjeni uz metode medicinski potpomognute oplodnje.

Datum pretraživanja: u sustavni pregled uključeni su dokazi dostupni do srpnja 2013.

Obilježja istraživanja: u literaturi je pronađeno 20 randomiziranih kontroliranih istraživanja. Šest istraživanja uspoređivalo je primjenu akupunkturu za vrijeme procesa skupljanja jajnih stanica prije postupka medicinski potpomognute oplodnje (uzorak od 912 žena), a 14 istraživanja je uspoređivalo primjenu akupunkture tijekom postupka medicinski potpomognute oplodnje (uzorak od 3632 žena). U dijelu istraživanja su ispitanici razvrstani u kontrolnu grupu u kojoj su se koristile placebo igle za akupunkturu, a u drugim istraživanjima u grupu u kojoj ispitanici nisu podvrgnuti nikakvom tretmanu. Sva istraživanja su uključivala ispitanike koji su bili podvrgnuti vanmaterničnoj (in vitro) oplodnji (eng. IVF). Nisu pronađena istraživanja o učinku akupunkture na indukciju ovulacije ili intrauterinu inseminaciju (ubacivanje obrađene sperme u maternicu).

Financiranje istraživanja: navedena istraživanja nisu financirali vanjski sponzori.

Ključni rezultati: nema dokaza o korisnom djelovanju akupunkture kod ispitanika podvrgnutih medicinski potpomognutoj oplodnji za vrijeme prijenosa embrija ili za vrijeme skupljanja jajnih stanica prije postupka medicinski potpomognute oplodnje, u vidu poboljšanja postotka uspješnih trudnoća kao i uspješnih pokušaja prirodnog ili medicinski potpomognutog začeća. Također ne postoje dokazi da akupunktura ima utjecaja na postotak pobačaja, niti da je imala značajne nuspojave.

Kvaliteta dokaza: rezultati nisu bili slični u svim istraživanjima. Razlog tome je različit ustroj istraživanja kao i primjena različitih vrsta kontrolnih grupa. Potrebno je provesti još istraživanja prije nego se mogu dati preporuke za takvu upotrebu akupunkture, uključujući istraživanja u kojima će se na ispitanicima raditi placebo akupunktura kao i analiziranje skupina na kojima nije proveden nikakav zahvat.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Maja Matković
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Summary of findings(Explanation)

Summary of findings for the main comparison. Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture) for women undergoing ART
  1. 1 Neither study clearly reported method of random sequence generation, one did not clearly describe method of allocation concealment
    2 Only two studies (n=464), wide confidence intervals.

Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture) for women undergoing assisted reproductive technology (ART)
Population: women undergoing ART
Intervention: Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture)
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture)
Live birth rate 357 per 1000 326 per 1000
(247 to 418)
OR 0.87
(0.59 to 1.29)
464
(2 studies)
⊕⊕⊝⊝
low 1,2
No significant difference in live birth rate was found between the two groups
*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 2 Acupuncture on the day of ET versus control for women undergoing ART

Summary of findings 2. Acupuncture on the day of ET versus control for women undergoing ART
  1. 1 Two studies did not describe method of random sequence generation; six did not clearly describe method of allocation concealment
    2 High statistical heterogeneity (I-squared =69%)
    3 Wide confidence intervals

Acupuncture on the day of embryo transfer (ET) versus control for women undergoing assisted reproductive technology (ART)
Population: women undergoing ART
Intervention: Acupuncture on the day of ET versus control (sham, placebo, no acupuncture)
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Acupuncture on the day of ET versus control
Live birth rate 281 per 1000 323 per 1000
(254 to 399)
OR 1.22
(0.87 to 1.7)
2505
(8 studies)
⊕⊕⊝⊝
low 1,2,3
No significant difference in live birth rate was found between the two groups
*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

One in seven to 10 couples in industrialised countries suffer from subfertility (Boivin 2007; Schmidt 1995). Many will seek medical help in the form of assisted reproductive technologies (ART), including controlled ovarian stimulation (COS) with or without intrauterine insemination (IUI) and in vitro fertilisation (IVF) treatment. The use of acupuncture has increasing gained popularity (Fisher 1994; Klein 2012; Thomas 2001) although its use as an adjuvant treatment to assisted conception is still controversial (El-Toukhy 2010; Huang 2011; Meldrum 2013).

Description of the intervention

Acupuncture is an integral part of traditional Chinese medicine (TCM) and can be dated back at least 3000 years. In Europe, from consumer surveys (Fisher 1994; Klein 2012; Thomas 2001) between 7% and 19% of the population report using acupuncture for various reasons, and studies have shown promising results for its efficacy in adult postoperative and chemotherapy induced nausea and vomiting (Garcia 2013; Holmer 2012; NIH Consensus 1998).

In its original form, acupuncture is based on the principles of TCM and involves the insertion of fine needles into the skin along the meridians, providing a means of altering the flow of energy through the body (Vickers 1999). In a typical treatment, between four to 10 points are needled for 10 to 30 minutes. Needles can be stimulated by manual twirling or with a small electric current, as electro-acupuncture (EA). There have been few studies of the physiological effects of acupuncture on the male or female reproductive tract, although for many years acupuncture has been widely used as an adjuvant to ART. Opinion about the effectiveness of acupuncture in women undergoing assisted conception varies considerably. Some regard the traditional Chinese treatment as effective (Zheng 2012) whilst others consider acupuncture as primarily a placebo treatment (Meldrum 2013) or even as a treatment that is unscientific and futile (El-Toukhy 2010). It is, therefore, critical to examine the current evidence available using stringent methodology and analysis to evaluate the effectiveness of acupuncture in couples undertaking ART.

How the intervention might work

The mechanisms of action of acupuncture are largely unknown. Its influence on plasma beta-endorphin levels via the hypothalamic-pituitary-adrenal (HPA) axis (Chen 2004; Stener-Victorin 2000; Stener-Victorin 2001), on uterine artery blood flow (Stener-Victorin 1996) and analgesic actions have been described (Stener-Victorin 1999).

Why it is important to do this review

Given the controversy surrounding this topic, it is important to perform an up-to-date review so that subfertile couples, fertility practitioners and general practitioners are better informed of the benefits or harm of acupuncture in assisted conception.

Objectives

To determine the effectiveness and safety of acupuncture as an adjunct to ART cycles for male and female subfertility.

Methods

Criteria for considering studies for this review

Types of studies

Published and unpublished randomised controlled trials (RCTs) were included in the review. We excluded non-randomised studies (for example studies with evidence of inadequate sequence generation such as alternate days, patient numbers) as they are associated with a high risk of bias. We did not include crossover trials with no first phase data.

Types of participants

Participants in the trials had to meet all the following criteria to be included in the review.

Inclusion criteria:

  • primary (subfertility in couples who have never conceived) or secondary subfertility (couples who have subfertility after previously having children);

  • women undergoing ART;

  • any type of acupuncture at any or all time points before, during, or after ART with the intention to improve the ART outcome.

Exclusion criteria:

  • participants with any medical illness deemed a contraindication for ART or acupuncture treatment;

  • quasi-randomised controlled trials; or

  • crossover randomised controlled trials that did not provide pre-crossover data.

Types of interventions

RCTs comparing acupuncture treatment of participants (men or women, or both) versus no treatment, placebo or sham acupuncture during controlled ovarian stimulation (COS) with or without artificial stimulation by partner (± artificial insemination by husband (AIH)), IVF, or frozen-thawed embryo transfer (FET) treatment were considered.

We included studies using either traditional acupuncture, in which needles were inserted in classical meridian points, or contemporary acupuncture in which the needles were inserted in non-meridian or trigger points. The source of stimulation could be the hand, fine needle, moxibustion with warming needle, or electrical stimulation. We excluded studies of acupuncture treatment without needling, such as point injection, acupressure, laser acupuncture, tap-pricking, or cupping on pricked superficial blood vessels. We excluded trials comparing different acupuncture treatments alone.

The timing of acupuncture treatment was generally either around the time of oocyte retrieval or around the time of embryo transfer (ET) (a few days before, the day of, and a few days after).

Needling in the control groups could either be with a sham needle (for example Streitberger placebo needle, Asiamed, Pullach, Germany, where skin penetration does not occur because the tip of the needle is blunted) or normal acupuncture needles, needling an area not recommended by TCM practitioners for fertility treatment. The other type of control group had no needling treatment.

Specific interventions to be considered:

  1. acupuncture + ART versus no treatment, placebo, sham acupuncture + ART; i.e. all women received ART;

  2. acupuncture alone versus no treatment, placebo, sham acupuncture + ART;

  3. acupuncture versus acupuncture + ART.

Types of outcome measures

Primary outcomes

1. Live birth rate, defined as delivery of a live fetus after 20 completed weeks gestational age

Secondary outcomes

1. Ongoing pregnancy rate, defined as evidence of a gestational sac with fetal heart motion at greater than 12 weeks (12 to 18 weeks), confirmed with ultrasound

2. Clinical pregnancy rate, defined as evidence of a gestational sac with fetal heart motion measured at seven to eight weeks, confirmed with ultrasound

3. Adverse events including miscarriage, ectopic pregnancy, fetal abnormalities, side effects, ovarian hyperstimulation syndrome (OHSS) and infection

All rates were per woman randomised.

Search methods for identification of studies

Electronic searches

We searched the following electronic databases, trials registers and web sites.

  1. Menstrual Disorders and Subfertility Group (MDSG) Specialised Register (inception to 22.7.13).

  2. Ovid Cochrane Central Register of Controlled Trials (CENTRAL) (inception to 22.7.13).

  3. Ovid MEDLINE® In-Process & Other Non-Indexed Citations, Ovid MEDLINE® Daily and Ovid MEDLINE® (inception to22.7.13).

  4. Ovid EMBASE (01.01.10 to 22.7.13). EMBASE was only searched for recent records as the UK Cochrane Centre has handsearched EMBASE to this point and these trials are already in CENTRAL.

  5. Ovid PsycINFO (inception to 22.7.13).

  6. Ovid AMED (inception to 22.7.13).

Other electronic sources of trials included:

  1. Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library (http://www.cochrane.org/index.htm);

  2. ClinicalTrials.gov (http://clinicaltrials.gov/ct2/home);

  3. World Health Organization International Clinical Trials Registry Platform search portal (http://apps.who.int/trialsearch/);

  4. OpenSigle for Grey literature from Europe (http://opensigle.inist.fr/);

  5. China Academic Journal Electronic full text Database in China National Knowledge Infrastructure;

  6. Index to Chinese Periodical Literature.

There was no language restriction in these searches. The search strings are in the appendices.

Searching other resources

We also handsearched reference lists of articles retrieved by the search and contacted experts in the field to obtain additional data when required. We handsearched relevant journals and conference abstracts that are not covered in the MDSG register, in liaison with the Trials Search Co-ordinator.

Data collection and analysis

Selection of studies

After an initial screening of titles and abstracts that were retrieved by the search, conducted by YC and SD, the full texts of all potentially eligible studies were retrieved. Two review authors (YC and SD) independently examined these full text articles for compliance with the inclusion criteria and selected studies eligible for inclusion in the review. We corresponded with study investigators to clarify study data and eligibility. Disagreements as to study eligibility were resolved by discussion without requiring referral to a third review author (WL). Study investigators were contacted for further data on methods or results, as required.

The selection process is documented with a PRISMA flow chart in Figure 1.

Figure 1.

Study selection PRISMA flow diagram.

Data extraction and management

Two review authors (YC and SD) independently extracted data and assessed trial quality using forms designed according to Cochrane guidelines. Disagreements as to study eligibility were resolved by discussion without requiring referral to a third review author (WL). Where studies had multiple publications, the main trial report was used as the reference and additional details were derived from secondary papers. We corresponded with study investigators to clarify further data on methods and results.

Assessment of risk of bias in included studies

The included studies were assessed for risk of bias using the Cochrane risk of bias assessment tool (Cochrane Handbook for Systematic Reviews of Interventions Version 5.1) to assess the following domains: random sequence generation; allocation concealment; blinding; incomplete outcome data; selective reporting; and other bias.

Two authors (YC and SD) independently assessed these six domains, with any disagreements resolved by consensus or by discussion with the third author (WL).

As this was a review of surgical studies, where blinding was not possible, absence of blinding was not considered a significant source of bias. Risk of bias assessment is summarised (Figure 2 and Figure 3).

Figure 2.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Figure 3.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

We took care to search for within trial selective reporting.

Measures of treatment effect

We performed statistical analysis in accordance with the guidelines and methods developed by The Cochrane Collaboration (Higgins 2011). All data were dichotomous. We expressed results for each study as odds ratio (OR) with 95% confidence interval (CI).

Unit of analysis issues

The unit of analysis was per participant and not per cycle. Multiple live births were counted as one live birth event.

Dealing with missing data

The data was analysed on an intention-to-treat basis and we have attempted to obtain missing data from the original trialists. Where these were unobtainable, imputation of individual values was undertaken for the primary outcomes only. Live births were assumed not to have occurred in participants without a reported outcome. For other outcomes, only the available data were analysed.

Assessment of heterogeneity

Heterogeneity was assessed using the I2 statistic, according to the guidelines set out in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). An I2 value greater than 50% indicated substantial heterogeneity.

Assessment of reporting biases

In view of the difficulty in detecting and correcting for publication bias and other reporting bias, we minimised their potential impact by ensuring a comprehensive search for eligible studies and by being aware of duplicated data. In the case where 10 or more studies were present in our analysis, we used a funnel plot to explore the possibility of a small study effect.

Data synthesis

Where possible, we pooled the outcomes and combined them for meta-analysis. Dichotomous data for primary and secondary outcomes in studies that were sufficiently similar were combined with RevMan software using the Peto-modified Mantel-Haenszel method and fixed-effect and random-effects models in the following comparisons.

1. Acupuncture around the time of oocyte retrieval versus control (changed for consistency).

2. Acupuncture on the day of ET versus control.

We used a fixed-effect model and examined heterogeneity between the results of different studies by inspecting the scatter in the data points, the overlap in their CIs, and more formally by checking the results of the Chi2 test and the I2 statistic. An I2 greater than 50% was taken to indicate substantial heterogeneity and in that case a random-effects analysis was used.

Subgroup analysis and investigation of heterogeneity

The analysis was stratified to examine the separate evidence within the following subgroups:

1) studies with control groups that had sham or needling acupuncture;

2) studies with control groups that had no acupuncture.

Sensitivity analysis

None applicable

Results

Description of studies

See the tables Characteristics of included studies and Characteristics of excluded studies.

Results of the search

In the original review, 16 randomised trials were identified involving acupuncture and assisted conception; 13 met the inclusion criteria and three were excluded. In the updated search, 14 further randomised trials were identified, giving a total of 30. In total, 20 trials were included and nine were excluded; see Figure 1. Five ongoing studies were also identified (ACTRN12611000226909; IRCT201011275181N4; NCT00317317; NCT01449396; NCT01608048).

Included studies

Study design and setting

Twenty randomised controlled trials were included in this review. Four of the trial reports were abstracts (Benson 2006; Craig 2007; Fraterelli 2008; Paulus 2003). All 20 trials had a parallel design (Andersen 2010; Benson 2006; Craig 2007; Dieterle 2006; Domar 2009; Fraterelli 2008; Gejervall 2005; Ho 2009; Humaidan 2004; Madaschi 2010; Moy 2011; Paulus 2002; Paulus 2003; Sator-K 2006; Smith 2006; So 2009; So 2010; Stener-Victorin 1999; Stener-Victorin 2003; Westergaard 2006).

Participants

The studies included a total of 4544 participants. All were women undergoing IVF and intracytoplasmic sperm injection (ICSI). The characteristics of the participants can be found in the table Characteristics of included studies.

Interventions

A summary of the acupuncture points used in the various studies is provided in Table 1.

Table 1. Table 1. Summary of acupuncture points used.
Acupuncture points Craig 2007 Westergaard 2006 Dieterle 2006 Paulus 2002 Paulus 2003 Andersen 2010; Domar 2009 Madaschi 2010 Ho 2009 Moy 2011 Smith 2006 So 2009 So 2010 Stener-Victorin 1999 Stener-Victorin 2003 Gejervall 2005 Humaidan 2004 Sator-K 2006
Cv6 (Qi Hai)Y (before ET)     Y        
Cx6 (Neiguan)Y  Y   Y       

DU 20

(bai hui)

      Y        
GV 20 (Baihui)YY (around ET and ET + 2) YY  YY YYYYY
Liv 2 (Xingjian)               
Liv 3 (Taichong)Y  Y  YY       
LI 4 (Hegu)YY ( ET + 2)Y (ET + 3)YY YYYYYYYYY
LI 10 (Shoushanli)            Y  
LR 3 (Taichong) Y  YY  Y      

LU 7

(lieque)

   Y           
SP 6 (Sanyinjiao)YY ( ET + 2)Y (ET + 3)YYYYYYY   YY
SP 8 (Diji)YYYYY YYY      
SP 10 (Xuehai)Y YYY YYYY     
ST28     Y         
ST29 (Guilai)YY (ET and ET + 2)YYY YYY YYY  
ST36 (Zushanli)Y Y (ET + 3)YY YYYYYYY  
PC6 (Neiguan) YY Y   Y      
Ren 3 (Zhongji) Y (ET + 2)             
RN 4 (Guanyuan)  Y  Y         
RN6 (Qihai)  Y  Y         
K3 (Tai Xi)Y (after ET)              
K13 (Taxiu)  Y (ET + 3)            
K1 11(Henggu)Y          Y   
TE 5 (Weiguan)            Y  
EX-CA 1 (Zigong)     Y         
Control groups

No sham or needling:

With sham or needling:

Outcomes
  • 11/20 studies reported on live birth rate

  • 11/20 studies reported on ongoing pregnancy rate

  • 20/20 studies reported on clinical pregnancy rate

  • 2/20 studies reported on multiple pregnancy rates

  • 0/20 studies reported on rates of OHSS

  • 9/20 studies reported on miscarriage rates

  • 4/20 studies reported on side effects arising from use of acupuncture

Further details of the included studies can be found in the table Characteristics of included studies.

Excluded studies

Ten studies were excluded from the review for the following reasons:

  • Quintero 2004 was excluded due to the lack of first phase results in its crossover design;

  • Cui 2011 randomised women with polycystic ovary syndrome (PCOS) undergoing ET to either electro-acupuncture (n = 34) or the control of no treatment (n = 32). However, the description of the randomisation process showed a high risk of bias with an inadequate randomisation process, based on odd or even numbers;

  • Chen 2004; Chen 2009; Cui 2007; Evans 2005; Feliciani 2011; Li 2009 and Omodei 2010 were excluded because they were apparently not randomised.

  • Chen 2012 reported on supplementary analgesia and improvement of adverse reactions induced by dolantin in oocyte retrieval, which were not outcoems of interest in the review

Characteristics of excluded studies can be found in the table Characteristics of excluded studies.

Risk of bias in included studies

Risk of bias assessment focused on six main domains: random sequence generation, allocation concealment, blinding, incomplete data outcome, selective reporting and other potential bias. Details of the findings can be found in the relevant risk of bias summary figures (Figure 2; Figure 3) and the Characteristics of included studies table.

Allocation

Sequence generation

Eleven trials were at low risk of selection bias related to sequence generation (Andersen 2010; ; Domar 2009; Gejervall 2005; Madaschi 2010; Moy 2011; Paulus 2002; Paulus 2003; Sator-K 2006; Smith 2006; So 2009; So 2010; ). The other nine trials (Benson 2006; Craig 2007; Dieterle 2006; Fraterelli 2008; Ho 2009; Humaidan 2004; Stener-Victorin 1999; Stener-Victorin 2003; Westergaard 2006)were at an unclear risk due to a lack of detail of their methods of sequence generation.

Allocation concealment

Four trials were at low risk of bias for allocations concealment (Humaidan 2004; Moy 2011; So 2009; So 2010). The other sixteen trials (Andersen 2010; Benson 2006; Craig 2007; Dieterle 2006; Domar 2009; Fraterelli 2008; Gejervall 2005; Ho 2009; Madaschi 2010; Paulus 2002; Paulus 2003; Sator-K 2006; Smith 2006; Stener-Victorin 1999; Stener-Victorin 2003; Westergaard 2006) were at unclear risk of bias for allocation concealment.

Blinding

Due to the nature of the studies, double blinding was often not possible. Eleven trials (Benson 2006; Craig 2007; Domar 2009; Gejervall 2005; Ho 2009; Madaschi 2010; Paulus 2002; Sator-K 2006; Stener-Victorin 1999; Stener-Victorin 2003; Westergaard 2006) had no sham acupuncture intervention for the control group and so were at high risk of performance and detection bias. Five trials (Andersen 2010; Humaidan 2004; Paulus 2003; So 2009; So 2010) were low risk of performance and detection bias due to the use of sham acupuncture controls for blinding. Moy 2011 and Dieterle 2006 used an actual needling procedure on acupoints that were not considered to affect fertility and so were also low risk. Smith 2006 used sham acupuncture for the control groups but was deemed at an unclear risk of performance and detection bias as, after the 3rd session, 24 in the treatment group and 10 in the control group had guessed their allocation correctly.

Incomplete outcome data

Fifteen trials were at low risk of attrition bias without significant incomplete outcome data (Andersen 2010; Craig 2007; Dieterle 2006; Gejervall 2005; Humaidan 2004; Madaschi 2010; Moy 2011; Paulus 2002; Paulus 2003; Sator-K 2006; So 2009; So 2010; Stener-Victorin 1999; Stener-Victorin 2003; Westergaard 2006). In three trials the risk was unclear as they did not report on the number of participants who completed the study (Benson 2006; Domar 2009; Fraterelli 2008). Ho 2009 had a high risk of attrition bias as 12 of the 26 control group participants dropped out of the trial. Smith 2006 also had a high risk of attrition bias as 36 women (15%) were withdrawn from the trial after randomisation.

Selective reporting

Three trials (Andersen 2010; So 2009; So 2010) were at low risk of reporting bias as they reported live birth data as prestated outcomes. Seven trials (Dieterle 2006; Humaidan 2004; Madaschi 2010; Paulus 2002; Paulus 2003; Stener-Victorin 2003; Westergaard 2006) were at unclear risk of reporting bias as they reported live birth data but it was not a prestated outcome. The remaining 10 trials (Benson 2006; Craig 2007; Domar 2009; Fraterelli 2008; Gejervall 2005; Ho 2009; Moy 2011; Sator-K 2006; Smith 2006; Stener-Victorin 1999) did not report on live birth rate outcomes and so were also at unclear risk.

Other potential sources of bias

One study (Stener-Victorin 1999) was rated as at unclear risk of other potential bias, related to co-intervention in some women. The other studies were rated as at low risk of bias in this domain.

Effects of interventions

See: Summary of findings for the main comparison Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture) for women undergoing ART; Summary of findings 2 Acupuncture on the day of ET versus control for women undergoing ART

Overall, 20 studies were included in the meta-analysis. The most commonly used acupuncture points were: GV 20, LI 4, SP6, and ST 29 (Table 1). A summary of the intended treatment with the various acupuncture points is given in Table 2.

Table 2. Table 2. Summary of the treatment intended for the respective acupuncture points
Acupuncture pointsIntended treatment
Cx6 (Neiguan)Location: 2 cun above the transverse crease of the wrist, between the tendons of muscle palmaris longus and muscle flexor radialis.

Indications
Cardiac pain, palpitation, stuffy chest, pain in the hypochondriac region, stomach ache, nausea, vomiting, hiccups, mental disorders, epilepsy, insomnia, febrile diseases, irritability, malaria, contracture and pain in elbow and arm.

Traditional action
Opens the chest, regulates heart Qi and blood, regulates and clears the Triple Burner, calms the mind, regulates the terminal Yin, harmonizes the stomach.
GV 20 (Baihui)Location: on the midline of the head, 7 cun directly above the posterior hairline, approximately on the midpoint of the line connecting the apexes of the two auricles.

Indications
Headache, vertigo, tinnitus, nasal obstruction, aphasia by apoplexy, coma, mental disorders, prolapse of the rectum and the uterus.

Traditional action
Clears the mind, lifts the spirits, tonifies yang, strengthens the ascending function of the spleen, eliminates interior wind, promotes resuscitation.
Liv 2 (Xingjian)Location: on the dorsum of the foot between the 1st and 2nd toes, proximal to the margin of the web at the junction of the red and white skin.

Point associations:
Ying Spring point
Fire point

Actions and effects:
Generally, clears LV Fire - extreme irritability, red face, eyes, tongue.
Clears heat from the lower Jiao - burning urination.
Useful for "true heat, false cold" - lack of Qi flow to the extremities (cold hands or feet).
Liv 3 (Taichong)Location: on the dorsum of the foot in a depression distal to the junctions of the 1st and 2nd metatarsal bones.

Point associations:
Shu Stream point
Earth point
Yuan source point

Actions and effects:
Generally, resolves stagnation and tonifies Yin - balancing for all LV pathologies.
LV Qi Stagnation, LV Yang Rising - headaches, dizziness, canker sores.
Eye issues - blurred vision, red, swollen, painful eyes.
Menstrual issues from deficient blood, Yin, Qi, LV Qi stagnation - dysmenorrhea, amenorrhoea, PMS, breast tenderness.
Genital issues - pain and swelling, hernia, impotence, seminal emission.
Stagnation in the middle warmer - subcostal tension, chest or flank pain, swellings in the axillary region.
Digestive issues from LV attacking ST/SP - nausea, vomiting, constipation, diarrhoea with undigested food.
Calming point - anger, irritability, insomnia, anxiety.
With LI 4, four gates treatment - powerfully effects the flow of Qi and blood in the body.
Location: On the dorsum of the foot in a depression distal to the junctions of the 1st and 2nd metatarsal bones.

Point associations:
Shu Stream point
Earth point
Yuan source point

Actions and effects:
Generally, resolves stagnation and tonifies Yin - balancing for all LV pathologies.
LV Qi Stagnation / LV Yang Rising - headaches, dizziness, canker sores.
Eye issues - blurred vision, red, swollen, painful eyes.
Menstrual issues from deficient blood, Yin, Qi a/or LV Qi stagnation - dysmenorrhea, amenorrhoea, PMS, breast tenderness.
Genital issues - pain and swelling, hernia, impotence, seminal emission.
Stagnation in the middle warmer - subcostal tension, chest/flank pain, swellings in the axillary region.
Digestive issues from LV attacking ST/SP - nausea, vomiting, constipation, diarrhoea with undigested food.
Calming point - anger, irritability, insomnia, anxiety.
With LI 4, four gates treatment - powerfully effects the flow of Qi and blood in the body.
LI 4 (Hegu)Location: in the middle of the 2nd metacarpal bone on the radial side.

Precautions: no moxa, no needle in pregnancy.

Point associations:
Yuan source point
Entry point
Command point for face, nose, mouth and jaw

Actions and effects:
Releases the exterior for wind-cold or wind-heat syndromes.
Strengthens the wei qi, improves immunity.
Regulates the sweat glands, for excessive sweating tonify LI 4 then disperse KD 7 and vice versa.
Any problem on the face - sense organs, mouth, teeth, jaw, toothache, allergies, rhinitis, hay fever, acne, eye problems, etc.
Toothache use both LI 4 & ST 44 - LI for the lower jaw & ST for the upper jaw.
Headache, especially frontal, sinus (yangming area).
Chronic pain.
Influence the circulation of Qi and blood - use the four gates, LI 4 & LV 3 to strongly move the Qi and blood in the body clearing stagnation and alleviating pain.
Promote labor or for retained placenta.
LI 10 (Shoushanli)

Location: 2 cm below LI 11 on the LI 5 to LI 11 line.

Actions and effects:
The following relationships exist between the ST and the LI and can be used to treat ST, LI and SI organ problems.
SI: LI 8 & ST 39.
LI: LI 9 & ST 37.
ST: LI 10 & ST 36.
Shoulder, elbow and wrist pain issues, general aches in these areas.
Less dispersive and more tonifying than other LI points.
Epigastric and abdominal pain, ulcers, vomiting.

Location: 2 cm below LI 11 on the LI 5 to LI 11 line.

SP 6 (Sanyinjiao)Location: 3 cm directly above the tip of the medial malleolus on the posterior border of the tibia.


Precautions: no needle in pregnancy

Point associations:
Intersection point of the SP, LV and KD (3 leg yin meridians)

Actions and effects:
Tonify Yin and blood, all spleen disorders.
Digestive disorders, sinking or prolapse.
Gynecological issues, male sexual issues, difficult labor (expel fetus).
Bleeding disorders, cool blood in hot skin diseases.
Insomnia and other anxiety related emotions.
SP 8 (Diji)Location: 3 cm below SP 9 on line connecting SP 9 and the tip of the medial malleolus.

Point associations:
Xi Cleft point.


Actions and effects:
Xi Cleft point - acute and painful menstrual issues due to blood stagnation - clotting, fibroids, dysmenorrhoea.
Male infertility.
SP 10 (Xuehai)Location: with knee flexed, 2 cm above the superior medial border of the patella on the bulge of the medial portion of quadriceps femoris (vastus medialis).

Actions and effects:
Any gynaecological issues originating from blood, heat, stasis and/or deficiency - irregular menstruation, cramping, PMS.
Skin problems from damp-heat or hot blood.
ST29 (Guilai)Location: 2 cm lateral to the AML level with CV 3.

Actions and effects:
Excess or cold/deficient disorders of the lower warmer - amenorrhoea, irregular menstruation, qi stagnation/masses.
Running Piglet disorder.
ST36 (Zushanli)Location: 3 cm below ST 35, one finger width lateral from the anterior border of the tibia.

Point associations:
He Sea point
Lower Lower He Sea point of the ST
Earth point
Sea of Water and Grain point
Command point of the abdomen

Actions and effects:
Tonify deficient Qi or blood.
Tonify Wei Qi.
All issues involving the stomach or the spleen.
Clear disorders along the course of the channel - breast problems, lower leg pain.
Earth as the mother of Metal - will support lung function in cases of asthma, wheezing, dyspnoea.
Psychological/Emotional disorders - PMS, depression, nervousness.
PC6 (Neiguan)Location: 2 cm above the wrist crease between the tendons of palmaris longus and flexor carpi radialis.

Point associations:
Luo Connecting point
Yin Wei Master point coupled with SP 4

Actions and effects:
Similar to PC 3 but more for chronic heart symptoms from Qi stagnation.
Opens and relaxes the chest, chest tightness, asthma, angina, palpitations.
Insomnia, other spirit disorders of an excess or deficient nature, mania, nervousness, stress, poor memory.
Nausea, seasickness, motion sickness, vomiting, epigastric pain.
Carpal tunnel syndrome.
Ren 3 (Zhongji)Location (zhongji): 1 cm superior to qugu. Regulates LR, warms KI, irregular menses.
RN 4 (Guanyuan)Location: 1.5 cm lateral to the Du meridian, at the level of the lower border of the spinous process of the 5th lumbar vertebra.

Indications
Low back pain, abdominal distension, diarrhoea, enuresis, sciatica, frequent urination.

Traditional action
Strengthens the lower back, removes obstructions from the channel.
RN6 (Qihai)Location: 1.5 cm lateral to the Du meridian, at the level of the lower border of the spinous process of the third lumbar vertebra.

Indications
Low back pain, irregular menstruation, dysmenorrhoea, asthma.

Traditional action
Strengthens lower back, removes obstructions fro mchannel, regulates Qi and blood.
KI 3 (Taixi)Location: in the depression between the medial malleolus and tendo calcaneus, at the level with the tip of the medial malleolus.

Indications
Sore throat, toothache, deafness, tinnitus, dizziness, spitting of blood, asthma, thirst, irregular menstruation, insomnia, nocturnal emission, impotence, frequency of micturition, pain in the lower back.

Traditional action
Tonifies the kidneys, benefits essence, strengthens the lower back and knees, regulates the uterus.
KI 11 (Henggu)Location: 1.5 cm posterior to Wuchu (UB 5), 1.5 cm lateral to the Du meridian.

Indications
Headache, blurring of vision, nasal obstruction.

Traditional action
Clears heat and eliminates vexation, brightens the eyes and opens the portals.
TE 5 (Weiguan)Location: 1.5 cm lateral to the lower border of the spinous process of the eighth thoracic vertebra.

Indications
Diabetes, vomiting, abdominal pain, pain in the chest and hypochorondriac region.

Traditional action
Relieves stagnation of blood.

1. Acupuncture around the time of oocyte retrieval

None of the studies with the intervention performed around the time of oocyte retrieval had controls using sham or needling acupuncture.

1.1 Live birth rate (LBR)

Two studies (Humaidan 2004; Stener-Victorin 2003) reported on the LBR. There was no evidence of a difference in the LBR between the treatment group (75/229) and the control group (84/235) (OR 0.87, 95% CI 0.59 to 1.29, I2 = 0%) (Analysis 1.1; Figure 4).

Figure 4.

Forest plot of comparison: 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), outcome: 1.1 Live Birth Rate.

1.2 Ongoing pregnancy rate

Two trials (Humaidan 2004; Stener-Victorin 2003) reported an ongoing pregnancy rate of 78/229 in the treatment group versus 88/235 in the control group (OR 0.86, 95% CI 0.58 to 1.26, I2 = 0%) (Analysis 1.2).

1.3 Clinical pregnancy rate

In the pooled results of six trials (Gejervall 2005; Ho 2009; Humaidan 2004; Sator-K 2006; Stener-Victorin 1999; Stener-Victorin 2003), there was no evidence of a difference in the clinical pregnancy rate between the treatment group (174/478) and the control group 150/434 (OR 1.12, 95% CI 0.78 to 1.62, P = 0.53, I2 = 34%) (Analysis 1.3).

1.4 Miscarriage rate

The pooled results from four trials (Humaidan 2004; Sator-K 2006; Stener-Victorin 1999; Stener-Victorin 2003) showed no significant difference in miscarriage rates between the treatment group and control: 25/142 versus 29/120 (OR 0.79, 95% CI 0.42 to 1.47, I2 = 17%) (Analysis 1.4; Figure 5).

Figure 5.

Forest plot of comparison: 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), outcome: 1.4 Miscarriage rate.

1.5 Multiple pregnancy

No trials reported multiple pregnancy.

1.6 Ovarian hyperstimulation syndrome (OHSS)

No trials reported OHSS.

2. Acupuncture on or around the day of embryo transfer

2.1 Live birth rate (LBR)

In women who had acupuncture on the day of and around ET (Andersen 2010; Dieterle 2006; Madaschi 2010; Paulus 2002; Paulus 2003; So 2009; So 2010; Westergaard 2006) (N = 2505), the overall LBR was 389/1302 compared to the controls 338/1203 (OR 1.22, 95% CI 0.87 to 1.70, P = 0.30, I2 = 69%) (Analysis 2.1; Figure 6). This was not statistically significant.

Figure 6.

Forest plot of comparison: 2 Acupuncture on and around the day of ET versus control, outcome: 2.1 Live Birth.

In studies that had controls without sham acupuncture or needling (Madaschi 2010; Paulus 2002; Westergaard 2006), the LBR in the acupuncture group was significantly higher at 154/474 compared to 90/375 (OR 1.55, 95% CI 1.14 to 2.12, I2 = 0%) in the controls. In the studies that had controls with sham acupuncture (Andersen 2010; Dieterle 2006; Paulus 2003; So 2009; So 2010) the results were 235/828 in the acupuncture group compared to 248/828 (OR 1.03, 95% CI 0.67 to 1.58, P = 0.88, I2 = 72%) in the controls. This was not statistically significant.

2.2 Ongoing pregnancy rate

In the pooled results of 10 trials (Andersen 2010; Craig 2007; Dieterle 2006; Fraterelli 2008; Paulus 2002; Paulus 2003; Smith 2006; So 2009; So 2010; Westergaard 2006) (N = 2807), the overall ongoing pregnancy rate was 460/1451 in the acupuncture group compared to 427/1356 for all controls (OR 1.10, 95% CI 0.80 to 1.52, P = 0.56, I2 = 72%) (Analysis 2.2).

In studies that had controls without sham acupuncture or needling (Craig 2007; Fraterelli 2008; Paulus 2002; Westergaard 2006), the ongoing pregnancy rate in the acupuncture group was 183/514 compared to 143/410 in the controls (OR 1.08, 95% CI 0.57 to 2.07, P = 0.81, I2 = 77%). In the studies that had controls with sham acupuncture (Andersen 2010; Dieterle 2006; Paulus 2003; Smith 2006; So 2009; So 2010) the results were 277/937 in the acupuncture group compared to 284/946 in the controls (OR 1.10, 95% CI 0.74 to 1.65, P = 0.63, I2 = 73%). This was not statistically significant .

2.3 Clinical pregnancy rate

In the pooled results of 14 trials (Andersen 2010; Benson 2006; Craig 2007; Dieterle 2006; Domar 2009; Fraterelli 2008; Madaschi 2010; Moy 2011; Paulus 2002; Paulus 2003; Smith 2006; So 2009; So 2010; Westergaard 2006) (N = 3632) the clinical pregnancy rate was 734/1876 in the acupuncture group compared to 658/1756 for all controls (OR 1.11, 95% CI 0.87 to 1.42, P = 0.39, I2 = 66%). This was not statistically significant (Analysis 2.3).

In studies that had controls without sham acupuncture or needling (Benson 2006; Craig 2007; Domar 2009; Fraterelli 2008; Madaschi 2010; Paulus 2002; Westergaard 2006) the clinical pregnancy rate in the acupuncture group was 365/853 compared to 285/736 (OR 1.21, 95% CI 0.84 to 1.73, P = 0.30, I2 = 62%). In the studies that had controls with sham acupuncture (Andersen 2010; Dieterle 2006; Moy 2011; Paulus 2003; Smith 2006; So 2009; So 2010) the results were 369/1023 compared to 373/1020 (OR 1.04, 95% CI 0.74 to 1.46, P = 0.83, I2 = 68%). This was not statistically significant.

2.4 Miscarriage rate

Six trials evaluated the possible impact of acupuncture on miscarriage (Dieterle 2006; Madaschi 2010; Smith 2006; So 2009; So 2010; Westergaard 2006). The miscarriage rate was 71/340 in the acupuncture group compared to 57/276 in the overall controls (OR 1.10, 95% CI 0.73 to 1.67, I2 = 0%) (Analysis 2.4; Figure 7). There was no significant difference found between the two groups in the subgroup analysis.

Figure 7.

Forest plot of comparison: 2 Acupuncture on and around the day of ET versus control, outcome: 2.4 Miscarriage.

2.5 Multiple gestations

Two trials reported on multiple pregnancy rates (Andersen 2010; Moy 2011); both had control groups which used sham acupuncture. There was no significant difference detected between the acupuncture (30/400) and control groups (25/395) (OR 1.32, 95% CI 0.74 to 2.35, I2 = 0%) (Analysis 2.5).

2. 6 Ovarian hyperstimulation syndrome (OHSS)

None of the 14 trials reported ovarian hyperstimulation.

2.7 Any side effects

So 2009 and So 2010 did not report any statistically significant difference between side effects in the 'real' and 'placebo' acupuncture groups; side effects included nausea, dizziness, fainting, tiredness, headache, chest pain and puncture site itching. However, Moy 2011 suggest a difference between the two groups in the main categories of the McGill pain score. Women in the true arm reported greater affective perception of being tired and fearful as well as more achiness.

Assessment of heterogeneity

Heterogeneity was generally absent or low when studies of acupuncture around the time of oocyte retrieval were pooled

However when analyses of studies of acupuncture on or around the day of embryo transfer were pooled there was high heterogeneity (I-squared >50%) for several outcomes, and we considered clinical and methodological differences between the studies that might account for this. The increased heterogeneity may be a result of the large variation in the definition of controls and acupuncture points used in the included studies (see below).

Discussion

Summary of main results

This updated review reports no evidence of overall benefit of acupuncture in improving live birth rate (LBR) when acupuncture was performed around the time of oocyte retrieval or on and around the day of ET.

The subgroup analysis showed that in studies with controls without sham or needling, women who had acupuncture on and around the day of ET had a higher LBR than the controls (OR 1.55, 95% CI 1.14 to 2.12); however this evidence of benefit was not present in studies where the control group had sham acupuncture (acupuncture compared to sham controls (OR 0.93, 95% CI 0.75 to 1.15). The difference in findings between the two subgroups could possibly be due to study quality: only two RCTs, both in the sham acupuncture group, reported satisfactory methods of allocation concealment.

There was no evidence that acupuncture had an effect on miscarriage rates or other treatment side effects.

Most authors in the field assume that acupuncture has little detrimental effect. Our review reports no evidence of effect on the miscarriage rate between acupuncture groups and all controls, regardless of the timing of the intervention. This data does not prove that acupuncture is free of harm in early pregnancy and one should apply caution when giving advice to women about undergoing acupuncture in early pregnancy.

Overall completeness and applicability of evidence

It is generally accepted that acupuncture is relatively painless and has few side effects, although recent studies have shown that serious adverse events can occur (He et al, 2012). Before routine treatment can be accepted into mainstream medicine, acupuncture needs to have proven efficacy. In other words, acupuncture has to be demonstrably more effective than placebo. However, the use of an appropriate placebo in this context is variable. The variety of controls used for the RCTs included in this review ranged across no intervention, placebo needling, and sham acupuncture needles. Although sham needles are regarded as an acceptable control, true patient blinding has been shown to be a challenge (Tan 2011). It is possible that acupuncture needling could elicit a placebo or true biological effect over a wide area of the body not specific to 'points'. It has been suggested that a placebo effect may positively influence reproductive outcomes through mechanisms related to stress relief (Domar 2011; Meissner 2007), although postulating the biological impact of placebo is very much outside the context of this review.

Studies included in this review also had a large variation in pregnancy rates, but most studies did not report their centre's normal pregnancy rate for comparison.

Although all 20 trials in this review examined the use of acupuncture for improving the pregnancy rate with IVF, different acupuncture points were selected to achieve the same objective and it is unclear why this is the case. In Western medicine, where the standardisation of methodology is of key importance in medical research, the absence of complete concordance of the acupuncture points in these studies is an unfamiliar concept. There is no consensus amongst practicing acupuncturists as to what constitutes a reasonable variation of the acupuncture treatment protocol. There is also no consensus as to how much experience or training an acupuncturist needs to provide effective acupuncture treatment, although courses are available that provide a license to practice the art.

At the time of writing this review, the authors knew of four further studies in the area that are ongoing (ACTRN12611000226909; IRCT201011275181N4; NCT00317317; NCT01449396).

Quality of the evidence

The overall quality of evidence for live birth outcomes was rated as low, using GRADE methods (see Summary of findings for the main comparison and Summary of findings 2). The quality of individual studies was generally low, with over 75% failing to describe an adequate method of allocation concealment (see Figure 2 and Figure 3 ).

Potential biases in the review process

We made every effort to identify all potentially eligible studies, and sought additional data from study authors as necessary. However, it is possible that there are unpublished studies that were not retrieved.

Agreements and disagreements with other studies or reviews

Several meta-analyses have been published in the last six years in this area (Anderson 2007; Cheong 2010; El-Toukhy 2010; Manheimer 2008; Zheng 2012). Depending on the data included and when the reviews were published, researchers have reached different conclusions about the beneficial effects on acupuncture on women undergoing IVF. Such discrepancies will continue to exist unless agreed standard scientific principles and research methodologies are incorporated into future studies (MacPherson 2010).

Authors' conclusions

Implications for practice

We found no evidence that acupuncture improves live birth rate, ongoing pregnancy rate or clinical pregnancy rate. We also found no evidence that acupuncture increases the rate of miscarriage.

Implications for research

Future research into the value of acupuncture in improving the pregnancy rate of women undergoing IVF treatment should incorporate basic scientific principles and methodologies. Within the realm of RCTs, studies in this area should focus on the use of 'standardised' acupuncture methods so that reasonable comparisons can be made; live birth rate should be used as the primary outcome.The use of 'sham needles' may enhance the quality of the studies performed, though further research into the biological effect of sham acupuncture is needed. Ideally, studies in this area should carefully consider how they determine the necessary treatment points, gather qualitative as well as quantitative data in parallel with a three arm study design, acupuncture, no intervention and placebo needling. They should also provide their centre's pregnancy rates during the time course of the study for comparison. It is with this comprehensive study design that any clinical benefit of acupuncture can be delineated.

Acknowledgements

We thank the Cochrane Menstrual Disorders and Subfertility Group for providing us with the search strategy and for proof reading the review.

Data and analyses

Download statistical data

Comparison 1. Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Live Birth Rate2464Odds Ratio (M-H, Fixed, 95% CI)0.87 [0.59, 1.29]
1.1 Acupuncture versus Control2464Odds Ratio (M-H, Fixed, 95% CI)0.87 [0.59, 1.29]
2 Ongoing Pregnancy Rate2464Odds Ratio (M-H, Fixed, 95% CI)0.86 [0.58, 1.26]
2.1 Acupuncture versus Control2464Odds Ratio (M-H, Fixed, 95% CI)0.86 [0.58, 1.26]
3 Clinical Pregnancy Rate6912Odds Ratio (M-H, Random, 95% CI)1.12 [0.78, 1.62]
3.1 Acupuncture versus Control6912Odds Ratio (M-H, Random, 95% CI)1.12 [0.78, 1.62]
4 Miscarriage rate4262Odds Ratio (M-H, Fixed, 95% CI)0.79 [0.42, 1.47]
4.1 Acupuncture versus Control4262Odds Ratio (M-H, Fixed, 95% CI)0.79 [0.42, 1.47]
Analysis 1.1.

Comparison 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), Outcome 1 Live Birth Rate.

Analysis 1.2.

Comparison 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), Outcome 2 Ongoing Pregnancy Rate.

Analysis 1.3.

Comparison 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), Outcome 3 Clinical Pregnancy Rate.

Analysis 1.4.

Comparison 1 Acupuncture around the time of oocyte retrieval versus control (sham, placebo, no acupuncture), Outcome 4 Miscarriage rate.

Comparison 2. Acupuncture on and around the day of ET versus control
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Live Birth82505Odds Ratio (M-H, Random, 95% CI)1.22 [0.87, 1.70]
1.1 Acupuncture versus Control (no sham/needling)3849Odds Ratio (M-H, Random, 95% CI)1.55 [1.14, 2.12]
1.2 Acupuncture versus Control (sham/needling)51656Odds Ratio (M-H, Random, 95% CI)1.03 [0.67, 1.58]
2 Ongoing pregnancy102807Odds Ratio (M-H, Random, 95% CI)1.10 [0.80, 1.52]
2.1 Acupuncture versus Control (no sham/needling)4924Odds Ratio (M-H, Random, 95% CI)1.08 [0.57, 2.07]
2.2 Acupuncture versus Control (sham/needling)61883Odds Ratio (M-H, Random, 95% CI)1.10 [0.74, 1.65]
3 Clinical pregnancy143632Odds Ratio (M-H, Random, 95% CI)1.11 [0.87, 1.42]
3.1 Acupuncture versus Control (no sham/needling)71589Odds Ratio (M-H, Random, 95% CI)1.21 [0.84, 1.73]
3.2 Acupuncture versus Control (sham/needling)72043Odds Ratio (M-H, Random, 95% CI)1.04 [0.74, 1.46]
4 Miscarriage6616Odds Ratio (M-H, Fixed, 95% CI)1.10 [0.73, 1.67]
4.1 Acupuncture versus Control (no sham/needling)2245Odds Ratio (M-H, Fixed, 95% CI)1.20 [0.57, 2.49]
4.2 Acupuncture versus Control (sham/needling)4371Odds Ratio (M-H, Fixed, 95% CI)1.06 [0.64, 1.76]
5 Multiple gestation2795Odds Ratio (M-H, Fixed, 95% CI)1.32 [0.74, 2.35]
5.1 Acupuncture versus Control (sham/needling)2795Odds Ratio (M-H, Fixed, 95% CI)1.32 [0.74, 2.35]
Analysis 2.1.

Comparison 2 Acupuncture on and around the day of ET versus control, Outcome 1 Live Birth.

Analysis 2.2.

Comparison 2 Acupuncture on and around the day of ET versus control, Outcome 2 Ongoing pregnancy.

Analysis 2.3.

Comparison 2 Acupuncture on and around the day of ET versus control, Outcome 3 Clinical pregnancy.

Analysis 2.4.

Comparison 2 Acupuncture on and around the day of ET versus control, Outcome 4 Miscarriage.

Analysis 2.5.

Comparison 2 Acupuncture on and around the day of ET versus control, Outcome 5 Multiple gestation.

Appendices

Appendix 1. MDSG search string

Menstrual Disorders and Subfertility Database Search strategy for IRS911

All reports which described randomised controlled trials of acupuncture in assisted conception were identified using the following search strategy.

Keywords CONTAINS "ART" or "assisted reproduction" or "assisted reproduction techniques" or "IVF" or "ICSI" or "in vitro fertilisation" or "in-vitro fertilisation techniques" or "in vitro fertilization" or "in vitro maturation" or "intracytoplasmic sperm injection" or "subfertility" or "Infertility" or "IUI" or "Intrauterine Insemination" or "*Embryo Transfer" or "ET" or Title CONTAINS "ART" or "assisted reproduction" or "assisted reproduction techniques" or "IVF" or "ICSI" or "in vitro fertilisation" or "in-vitro fertilisation techniques" or "in vitro fertilization" or "in vitro maturation" or "intracytoplasmic sperm injection" or "subfertility" or "Infertility" or "IUI" or "Intrauterine Insemination" or "*Embryo Transfer" or "ET"

AND

Keywords CONTAINS   "acupoint" or "acupressure" or "acupressure-acupuncture therapy" or "acupuncture" or "electro-acupuncture" or "electroacupuncture" or "moxibustion" or "Tui Na" or "ear electroacupuncture" or "ear point pressing" or Title CONTAINS"acupoint" or "acupressure" or "acupressure-acupuncture therapy" or "acupuncture" or "electro-acupuncture" or "electroacupuncture" or "moxibustion" or "Tui Na" or "ear electroacupuncture" or "ear point pressing"

Appendix 2. MEDLINE

Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) <1950 to Present>

1 exp reproduction techniques/ (101304)

2 exp fertility agents/ (24722)

3 (in vitro adj5 fertili$).tw. (16577)

4 ivf.tw. (12990)

5 icsi.tw. (4184)

6 (intracytoplas$ adj5 sperm$).tw. (4102)

7 subfertil$.tw. (2853)

8 (sperm$ adj5 inject$).tw. (5040)

9 suzi.tw. (101)

10 (subzon$ adj5 sperm$).tw. (110)

11 (zona adj5 dissect$).tw. (111)

12 pzd.tw. (61)

13 (ovar$ adj5 hyperstim$).tw. (3208)

14 ohss.tw. (899)

15 (oocyt$ adj5 retriev$).tw. (3100)

16 (oocyt$ adj5 pickup).tw. (48)

17 (sperm$ adj5 prepa$).tw. (1589)

18 (acrosom$ adj5 sperm$).tw. (4519)

19 (sperm$ adj5 stimul$).tw. (2014)

20 (sperm$ adj5 pentox$).tw. (114)

21 (sperm$ adj5 caff$).tw. (143)

22 (sperm$ adj5 kalli$).tw. (59)

23 (sperm$ adj5 swimup$).tw. (4)

24 (sperm adj5 percol$).tw. (239)

25 (embry$ adj5 biops$).tw. (563)

26 (cocult$ adj5 embry$).tw. (401)

27 (cocult$ adj5 trophobl$).tw. (33)

28 (luteal phase adj5 support).tw. (210)

29 (sperm$ adj5 cryopreserv$).tw. (1809)

30 (frozen adj5 embry$).tw. (1648)

31 (antisperm$ adj5 antibod$).tw. (1061)

32 (sperm$ adj5 antibod$).tw. (2406)

33 (artific$ adj5 inseminat$).tw. (4842)

34 (cervi$ adj5 inseminat$).tw. (201)

35 (fallopian tub$ adj5 perfus$).tw. (30)

36 (luteal adj5 defect$).tw. (375)

37 (luteal adj5 dysfunct$).tw. (82)

38 (ovulat$ adj5 induc$).tw. (6757)

39 (intraut$ adj5 inseminat$).tw. (1569)

40 (ectop$ adj5 preg$).tw. (7399)

41 (tub$ adj5 preg$).tw. (4499)

42 inseminat$.tw. (12887)

43 varicoc$.tw. (3433)

44 fertility/ (28979)

45 fertilization/ (11655)

46 insemination/ (630)

47 ovum implantation/ (8013)

48 Ovarian Hyperstimulation Syndrome/ (1424)

49 (embry$ adj5 transf$).tw. (16430)

50 or/1-49 (198724)

51 acupuncture/ (944)

52 exp acupuncture therapy/ (14092)

53 electroacupuncture/ (1949)

54 meridians/ (341)

55 acupuncture points/ (2977)

56 acupunctur$.tw. (12149)

57 (electroacupunctur$ or electro-acupunctur$).tw. (2370)

58 acupoint$.tw. (1825)

59 ((meridian or non-meridian or trigger) adj10 point$).tw. (1359)

60 exp Moxibustion/ (887)

61 (moxabustion or moxibustion or moxa$).tw. (2215)

62 or/51-61 (19443)

63 randomised controlled trial.pt. (307764)

64 controlled clinical trial.pt. (83549)

65 randomized.ab. (220349)

66 placebo.tw. (132278)

67 clinical trials as topic.sh. (153325)

68 randomly.ab. (163109)

69 trial.ti. (95112)

70 (crossover or cross-over or cross over).tw. (50660)

71 or/63-70 (747590)

72 exp animals/ not humans.sh. (3606997)

73 71 not 72 (691399)

74 50 and 62 and 73 (54)

75 (200710$ or 200711$ or 200712$).ed. (201896)

76 (2008$ or 2009$ or 2010$).ed. (2609966)

77 75 or 76 (2811862)

78 74 and 77 (23)

Appendix 3. CENTRAL

Database: EBM Reviews - Cochrane Central Register of Controlled Trials

1 exp reproduction techniques/ (2310)

2 exp fertility agents/ (1423)

3 (in vitro adj5 fertili$).tw. (1280)

4 ivf.tw. (1749)

5 icsi.tw. (600)

6 (intracytoplas$ adj5 sperm$).tw. (385)

7 subfertil$.tw. (124)

8 (sperm$ adj5 inject$).tw. (431)

9 suzi.tw. (13)

10 (subzon$ adj5 sperm$).tw. (19)

11 (zona adj5 dissect$).tw. (23)

12 pzd.tw. (6)

13 (ovar$ adj5 hyperstim$).tw. (506)

14 ohss.tw. (138)

15 (oocyt$ adj5 retriev$).tw. (547)

16 (oocyt$ adj5 pickup).tw. (7)

17 (sperm$ adj5 prepa$).tw. (98)

18 (acrosom$ adj5 sperm$).tw. (54)

19 (sperm$ adj5 stimul$).tw. (113)

20 (sperm$ adj5 pentox$).tw. (45)

21 (sperm$ adj5 caff$).tw. (7)

22 (sperm$ adj5 kalli$).tw. (16)

23 (sperm$ adj5 swimup$).tw. (0)

24 (sperm adj5 percol$).tw. (38)

25 (embry$ adj5 biops$).tw. (26)

26 (cocult$ adj5 embry$).tw. (20)

27 (cocult$ adj5 trophobl$).tw. (0)

28 (luteal phase adj5 support).tw. (122)

29 (sperm$ adj5 cryopreserv$).tw. (59)

30 (frozen adj5 embry$).tw. (114)

31 (antisperm$ adj5 antibod$).tw. (48)

32 (sperm$ adj5 antibod$).tw. (49)

33 (artific$ adj5 inseminat$).tw. (54)

34 (cervi$ adj5 inseminat$).tw. (19)

35 (fallopian tub$ adj5 perfus$).tw. (23)

36 (luteal adj5 defect$).tw. (34)

37 (luteal adj5 dysfunct$).tw. (10)

38 (ovulat$ adj5 induc$).tw. (535)

39 (intraut$ adj5 inseminat$).tw. (368)

40 (ectop$ adj5 preg$).tw. (170)

41 (tub$ adj5 preg$).tw. (139)

42 inseminat$.tw. (599)

43 varicoc$.tw. (106)

44 fertility/ (101)

45 fertilization/ (127)

46 insemination/ (3)

47 ovum implantation/ (313)

48 Ovarian Hyperstimulation Syndrome/ (121)

49 (embry$ adj5 transf$).tw. (1050)

50 or/1-49 (5752)

51 acupuncture/ (100)

52 exp acupuncture therapy/ (1824)

53 electroacupuncture/ (299)

54 meridians/ (25)

55 acupuncture points/ (662)

56 acupunctur$.tw. (3825)

57 (electroacupunctur$ or electro-acupunctur$).tw. (559)

58 acupoint$.tw. (687)

59 ((meridian or non-meridian or trigger) adj10 point$).tw. (256)

60 exp Moxibustion/ (117)

61 (moxabustion or moxibustion or moxa$).tw. (513)

62 or/51-61 (5069)

63 50 and 62 (34)

64 limit 63 to yr="2007 -Current" (13)

Appendix 4. EMBASE

Database: EBM Reviews - Cochrane Central Register of Controlled Trials

1 exp reproduction techniques/ (2310)

2 exp fertility agents/ (1423)

3 (in vitro adj5 fertili$).tw. (1280)

4 ivf.tw. (1749)

5 icsi.tw. (600)

6 (intracytoplas$ adj5 sperm$).tw. (385)

7 subfertil$.tw. (124)

8 (sperm$ adj5 inject$).tw. (431)

9 suzi.tw. (13)

10 (subzon$ adj5 sperm$).tw. (19)

11 (zona adj5 dissect$).tw. (23)

12 pzd.tw. (6)

13 (ovar$ adj5 hyperstim$).tw. (506)

14 ohss.tw. (138)

15 (oocyt$ adj5 retriev$).tw. (547)

16 (oocyt$ adj5 pickup).tw. (7)

17 (sperm$ adj5 prepa$).tw. (98)

18 (acrosom$ adj5 sperm$).tw. (54)

19 (sperm$ adj5 stimul$).tw. (113)

20 (sperm$ adj5 pentox$).tw. (45)

21 (sperm$ adj5 caff$).tw. (7)

22 (sperm$ adj5 kalli$).tw. (16)

23 (sperm$ adj5 swimup$).tw. (0)

24 (sperm adj5 percol$).tw. (38)

25 (embry$ adj5 biops$).tw. (26)

26 (cocult$ adj5 embry$).tw. (20)

27 (cocult$ adj5 trophobl$).tw. (0)

28 (luteal phase adj5 support).tw. (122)

29 (sperm$ adj5 cryopreserv$).tw. (59)

30 (frozen adj5 embry$).tw. (114)

31 (antisperm$ adj5 antibod$).tw. (48)

32 (sperm$ adj5 antibod$).tw. (49)

33 (artific$ adj5 inseminat$).tw. (54)

34 (cervi$ adj5 inseminat$).tw. (19)

35 (fallopian tub$ adj5 perfus$).tw. (23)

36 (luteal adj5 defect$).tw. (34)

37 (luteal adj5 dysfunct$).tw. (10)

38 (ovulat$ adj5 induc$).tw. (535)

39 (intraut$ adj5 inseminat$).tw. (368)

40 (ectop$ adj5 preg$).tw. (170)

41 (tub$ adj5 preg$).tw. (139)

42 inseminat$.tw. (599)

43 varicoc$.tw. (106)

44 fertility/ (101)

45 fertilization/ (127)

46 insemination/ (3)

47 ovum implantation/ (313)

48 Ovarian Hyperstimulation Syndrome/ (121)

49 (embry$ adj5 transf$).tw. (1050)

50 or/1-49 (5752)

51 acupuncture/ (100)

52 exp acupuncture therapy/ (1824)

53 electroacupuncture/ (299)

54 meridians/ (25)

55 acupuncture points/ (662)

56 acupunctur$.tw. (3825)

57 (electroacupunctur$ or electro-acupunctur$).tw. (559)

58 acupoint$.tw. (687)

59 ((meridian or non-meridian or trigger) adj10 point$).tw. (256)

60 exp Moxibustion/ (117)

61 (moxabustion or moxibustion or moxa$).tw. (513)

62 or/51-61 (5069)

63 50 and 62 (34)

64 limit 63 to yr="2007 -Current" (13)

Appendix 5. AMED

Database: AMED (Allied and Complementary Medicine)
1 (IVF or ICSI or IUI).tw. (29)

2 "embryo transfer".tw. (3)

3 ("in vitro fertilisation" or "in vitro fertilization").tw. (22)

4 ("intrauterine insemination" or "intracytoplasmic sperm injection").tw. (10)

5 exp Infertility female/ (122)

6 exp acupuncture therapy/ (5986)

7 acupuncture.tw. (8055)

8 exp Moxibustion/ (419)

9 (moxibustion or moxabustion or moxa$).tw. (498)

10 or/6-9 (8837)

11 or/1-5 (149)

12 10 and 11 (31)

13 limit 12 to yr="2007 -Current" (13)

Appendix 6. CINHAL

1 Controlled study/ or randomised controlled trial/
2 (drug$ adj5 compar$).ti,ab,hw,tn,mf.
3 placebo/
4 random$.ti,ab,hw,tn,mf.
5 latin square.ti,ab,hw,tn,mf.
6 crossover.ti,ab,hw,tn,mf.
7 cross-over.ti,ab,hw,tn,mf.
8 placebo$.ti,ab,hw,tn,mf.
9 ((doubl$ or singl$ or tripl$ or trebl$) adj5 (blind$ or mask$)).ti,ab,hw,tn,mf.
10 (comparative adj5 trial$).ti,ab,hw,tn,mf.
11 (clinical adj5 trial$).ti,ab,hw,tn,mf.
12 or/1-11
13 animal/ not (human/ and animal/)
14 12 not 13
15 exp reproduction techniques/
16 exp fertility agents/
17 (in vitro adj5 fertili$).tw.
18 ivf.tw.
19 icsi.tw.
20 (intracytoplas$ adj5 sperm$).tw.
21 subfertil$.tw.
22 (sperm$ adj5 inject$).tw.
23 suzi.tw.
24 (subzon$ adj5 sperm$).tw.
25 (zona adj5 sperm$).tw.
26 (zona adj5 dissect$).tw.
27 pzd.tw.
28 (ovar$ adj5 hyperstim$).tw.
29 ohss.tw.
30 (oocyt$ adj5 retriev$).tw.
31 (oocyt$ adj5 pickup).tw.
32 (sperm$ adj5 prepa$).tw.
33 (acrosom$ adj5 sperm$).tw.
34 (sperm$ adj5 stimul$).tw.
35 (sperm$ adj5 pentox$).tw.
36 (sperm$ adj caff$).tw.
37 (sperm$ adj5 kalli$).tw.
38 (sperm$ adj5 swimup$).tw.
39 (sperm adj5 percol$).tw.
40 (embry$ adj5 biops$).tw.
41 (cocult$ adj5 embry$).tw.
42 (cocult$ adj5 trophobl$).tw.
43 (luteal phase adj5 support).tw.
44 (sperm$ adj5 cryopreserv$).tw.
45 (frozen adj5 embry$).tw.
46 (antisperm$ adj5 antibod$).tw.
47 (sperm$ adj5 antibod$).tw.
48 (artific$ adj5 inseminat$).tw.
49 (cervi$ adj5 inseminat$).tw.
50 (fallopian tub$ adj5 perfus$).tw.
51 (luteal adj5 defect$).tw.
52 (luteal adj5 dysfunct$).tw.
53 (ovulat$ adj5 induc$).tw.
54 (intraut$ adj5 inseminat$).tw.
55 (ectop$ adj5 preg$).tw.
56 (tub$ adj5 preg$).tw.
57 inseminat$.tw.
58 varicoc$.tw.
59 fertility/
60 fertilization/
61 insemination/
62 ovum implantation/
63 Ovarian Hyperstimulation Syndrome/
64 (embry$ adj5 transf$).tw.
65 or/15-64
66 65 and 14
67 acupuncture/ or electroacupuncture/ or meridians/ or acupuncture points/
68 acupunctur$.tw.
69 (electroacupunctur$ or electro-acupunctur$).tw.
70 acupoint$.tw.
71 ((meridian or non-meridian or trigger) adj10 point$).tw.
72 exp MOXIBUSTION/
73 (moxibustion or moxabustion or moxa).tw.
74 or/67-73
75 66 and 74
76 from 75 keep 1-8

Appendix 7. PsycINFO

Database: PsycINFO

1 (IVF or ICSI or IUI).tw. (305)

2 "embryo transfer".tw. (74)

3 ("in vitro fertilisation" or "in vitro fertilization").tw. (405)

4 ("intrauterine insemination" or "intracytoplasmic sperm injection").tw. (28)

5 exp Reproductive Technology/ (1025)

6 exp Infertility/ (1378)

7 or/1-6 (2241)

8 exp Acupuncture/ (850)

9 acupuncture.tw. (1164)

10 Moxibustion.tw. (19)

11 (moxibustion or moxabustion or moxa$).tw. (24)

12 acupressure.tw. (76)

13 electroacupunture.tw. (1)

14 acu$ point$.tw. (97)

15 or/8-14 (1306)

16 7 and 15 (3)

What's new

DateEventDescription
23 July 2013New citation required but conclusions have not changedSeven new studies included in this update (Andersen 2010; Fraterelli 2008; Ho 2009; Madaschi 2010; Moy 2011; So 2009; So 2010)
23 July 2013New search has been performedUpdated review

History

Protocol first published: Issue 1, 2008
Review first published: Issue 4, 2008

DateEventDescription
13 June 2008AmendedConverted to new review format.
13 October 2007New citation required and conclusions have changedSubstantive amendment

Contributions of authors

Ying Cheong developed the selection criteria, wrote the review and performed the analysis. Ernest Ng co-authored the review. William Ledger acted as a moderator for the meta-analysis and co-wrote the review. Sarah Dix performed the analysis, and co-wrote the review.

Declarations of interest

Ernest Ng is an author for So 2009 and So 2010.

Sources of support

Internal sources

  • None, Not specified.

External sources

  • Cochrane Menstrual and Subfertility Group, New Zealand.

    Support of search strategy, advice, refereeing and proof reading

Differences between protocol and review

In the 2013 update the following changes were made.

A third comparison was added - acupuncture versus acupuncture + ART.

Ongoing pregnancy and clinical pregnancy rates were moved from primary to secondary outcomes.

The methodology section was rewritten with subheadings.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Andersen 2010

MethodsRandomised controlled trial of fertility patients in Denmark
Participants

Patients (n = 635) scheduled for embryo transfer were randomised into acupuncture according to the principles of Traditional Chinese Medicine (n = 314) or placebo acupuncture (n = 321).

The average age of the two groups of women was 31 years and the average body mass index (BMI) was 22.5 for both groups. There were similar numbers of previous IVF/ICSI cycles and similar proportions of causes of infertility between both groups.

InterventionsNeedle acupuncture or placebo acupuncture using Strietberger placebo needle for 25 minutes before and after embryo transfer; performed by nurses who were professional acupuncturists or by nurses who had received instruction and training by the acupuncturists prior to the trial
OutcomesOngoing pregnancy rate, implantation and pregnancy rates, live birth rates
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom sequence generation – LOW RISK - ‘the sequence of cluster randomization was based on a computer-generated list’
Allocation concealment (selection bias)Unclear risk‘nurses did the randomization with the sealed envelope technique’
Blinding (performance bias and detection bias)
All outcomes
Low riskSequence allocation was performed by nurses and the procedure was performed blinded to patients and the clinician performing ET
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo patients lost to follow up
Selective reporting (reporting bias)Low riskNone known
Other biasLow riskNone known

Benson 2006

MethodsRandomised controlled trial of fertility patients in US; abstract only
Participants

Patients (n = 258) who had been scheduled for ET were randomised into needle acupuncture (n = 53), laser acupuncture (n = 53), sham laser acupuncture (n = 52), relaxation treatment (n = 50) and no treatment (n = 50). For the purpose of this meta-analysis, only the results from the needle acupuncture and no treatment groups were used.

There were no details on the demographics as abstract only available

InterventionsNeedle acupuncture performed for 25 minutes before and after embryo transfer versus no intervention control group. There were no details on the qualifications of the acupuncturists as abstract only available
OutcomesClinical pregnancy rate
Assisted conception protocolsProtocol breakdown not provided
NotesEmailed authors for LBR but no reply
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskAbstract only; sequence generation not stated.
Allocation concealment (selection bias)Unclear riskAbstract only; allocation concealment not stated.
Blinding (performance bias and detection bias)
All outcomes
High riskNo sham needle group used, therefore blinding not possible
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk258 participants randomized but authors did not state the number of participants that completed the study.
Selective reporting (reporting bias)Unclear riskDid not report live birth
Other biasLow riskNone known

Craig 2007

MethodsMulticentre randomised control trial undertaken in the US; abstract only
Participants

107 patients undergoing IVF randomised women into two groups: one with acupuncture treatment (n = 48) and one without (n = 46).

There were no details on demographics as this report was presented as an abstract

InterventionsAcupuncture performed for 25 minutes before and after embryo transfer, against no intervention control group.There were no details on the qualifications of the acupuncturists as abstract only available.
OutcomesOngoing and clinical pregnancy rate
Assisted conception protocolsProtocol breakdown not provided
NotesNo information provided by authors
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskAbstract only; sequence generation not stated
Allocation concealment (selection bias)Unclear riskAbstract only; allocation concealment not stated.
Blinding (performance bias and detection bias)
All outcomes
High riskNo sham acupuncture control used
Incomplete outcome data (attrition bias)
All outcomes
Low risk107 participants randomized, 94 completed the study. 10 IVF cycles cancelled, 3 patients withdrew.
Selective reporting (reporting bias)Unclear riskDid not report live birth
Other biasLow riskNone known

Dieterle 2006

MethodsRandomised controlled trial, fertility patients in clinic in Germany
Participants

225 patients randomised: 116 to treatment and 109 to placebo. Treatment included placing Chinese herbs in patients' ears. No losses to follow up. Placebo treatment at sites that will not affect fertility, but physicians who were performing ET were blinded.

The average age (± SD) of the study group (n = 116) was 35.1 years (± 3.8) compared to 34.7 years (± 4) for the placebo group (n = 109). There were no statistical differences in the body mass index (BMI), causes of subfertility, and number of previous cycles between the study and control groups.

InterventionsTreatment included acupuncture + Chinese herbs in ears versus control group of acupuncture at sites that are not believed to affect fertility. The intervention was performed for 30 minutes after embryo transfer and again 3 days later. All acupuncture was performed by the same practitioner
OutcomesLive birth rate, clinical pregnancy rates and ongoing clinical pregnancy rates
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
NotesPlacebo group did not have drugs placed in ears
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot stated in the manuscript
Allocation concealment (selection bias)Unclear risk‘randomised with sealed randomization envelopes’ but not stated if these envelopes where opaque or sequentially numbered.
Blinding (performance bias and detection bias)
All outcomes
Low riskUse of placebo treatment in control group
Incomplete outcome data (attrition bias)
All outcomes
Low risk225 participants randomized; none lost to follow up.
Selective reporting (reporting bias)Unclear riskNot known whether LBR a prestated outcome
Other biasLow riskNone known

Domar 2009

MethodsRandomised controlled trial of fertility patients in the US
Participants

150 patients recruited and randomised to either needle acupuncture (n = 78) and no treatment (n=68).

The average age of the two groups of women was 36 years, with similar numbers of previous IVF cycles in the two groups.

InterventionsAcupuncture performed by an acupuncturist 25 minutes before and after embryo transfer versus no treatment control
OutcomesClinical pregnancy rate
Assisted conception protocolsProtocol breakdown not provided
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk‘randomisation was accomplished by using a computer-generated random numbers table’
Allocation concealment (selection bias)Unclear riskNot stated in the manuscript
Blinding (performance bias and detection bias)
All outcomes
High riskNot possible to blind as control group had no intervention
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk146 participants randomized but number completed not reported.
Selective reporting (reporting bias)Unclear riskNo LBR outcomes reported.
Other biasLow riskNone known

Fraterelli 2008

MethodsRandomised controlled trial of fertility patients in the US; abstract only
Participants

1000 patients randomised to five arms: needle acupuncture (n = 200), laser acupuncture (n = 202), sham laser acupuncture (n = 198), relaxation (n = 203) and non-treatment group (n = 197).

No demographics breakdown given but stated no difference between groups

InterventionsTwo treatment arms (laser and needle acupuncture) and three control arms (sham laser acupuncture, relaxation and non-treatment). For the purpose of this meta-analysis, only the results from the needle acupuncture and no treatment groups were used
OutcomesChemical and clinical pregnancy rate
Assisted conception protocolsProtocol breakdown not provided
NotesOnly needle acupuncture versus control are relevant to this review
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskAbstract only, no randomisation details given
Allocation concealment (selection bias)Unclear riskAbstract only, no details given
Blinding (performance bias and detection bias)
All outcomes
High riskControl group received no treatment
Incomplete outcome data (attrition bias)
All outcomes
Unclear risknot stated if all participants randomized completed the study
Selective reporting (reporting bias)Unclear riskNo LBR outcomes reported.
Other biasLow riskNone known

Gejervall 2005

MethodsOpen, randomised single-centre trial performed at the IVF unit of Reproductive Medicine at Sahlgrenska University Hospital in Goteborg
Participants

There were 160 women randomised in the study: 80 to the EA (electro-acupuncture) group and 80 to the CA (conventional acupuncture) group.

The average age of the women (± SD) in the control group (n = 80) was 33.9 years (± 3.7) compared to 33.2 years (± 3.6) in the intervention group; the average number of IVF cycles performed was 1.56 (± 0.93) compared to 1.48 (± 0.93). The majority of women had male factor or unexplained subfertility.

InterventionsThe study compared electro-acupuncture at the time of oocyte retrieval (EA group) with conventional analgesia (intravenous alfentanil). Both groups also had a paracervical block performed. Electro-acupuncture was performed by midwives who had been trained in the IVF unit.
Outcomes

Wellbeing was evaluated with the State Trait Anxiety Inventory (STAI). Pain and subjective expectations and experiences were recorded on a visual analogue scale (VAS). Time and drug consumption were recorded

Pregnancy rate was recorded as secondary outcome

Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
NotesStudy designed to assess effectiveness of acupuncture as an analgesic
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk‘randomisation was performed by the study coordinator according to a computerized list’
Allocation concealment (selection bias)Unclear riskNo details given
Blinding (performance bias and detection bias)
All outcomes
High riskConventional analgesia of I.V. alfentanil used as control analgesia. Therefore both participants and personnel not blinded. Not stated if assessor was blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk160 women randomized; 2 lost to follow up.
Selective reporting (reporting bias)Unclear riskNo LBR outcome reported.
Other biasLow riskNone

Ho 2009

MethodsRandomised study performed at the IVF centre of China Medical University Hospital in Taiwan
Participants

A total of 44 women were enrolled in the study: 30 were randomised to acupuncture group and 14 to the control (no-acupuncture group).

The two groups were described as comparable for demographics including age and cause of infertility

InterventionsThe study compared electro-acupuncture (twice a week for two weeks, from cycle day 2 to the day prior to oocyte retrieval) with no acupuncture around the time of oocyte retrieval
OutcomesOutcome measures studied were clinical pregnancy and the pulsatility index (PI) of left and right uterine arteries
Assisted conception protocolsProtocol breakdown not provided
NotesThe study was designed to assess the impact of acupuncture on uterine artery blood flow and clinical pregnancy rate
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot stated
Allocation concealment (selection bias)Unclear risk‘randomly assigned to one of the two groups by selection of a sealed envelope.’
Blinding (performance bias and detection bias)
All outcomes
High riskControl group received no treatment
Incomplete outcome data (attrition bias)
All outcomes
High risk30 randomised to acupuncture group, and 26 to control group (but 12 in the control group dropped out), leaving 30 in the acupuncture group and only 14 in the control group.
Selective reporting (reporting bias)Unclear riskNo LBR outcome data reported.
Other biasLow riskNone known

Humaidan 2004

MethodsRandomised trial of fertility patients in Denmark
Participants200 patients randomised to either electro-acupuncture (n = 100) or conventional analgesia (n = 100) at the time of oocyte retrieval. Both groups also received a para-cervical block.
InterventionsElectro-acupuncture at the time of oocyte retrieval, given by specially trained nurses, versus conventional analgesia control (benzodiazepine, alfentanil)
OutcomesVAS scale
Clinical pregnancy rate
Assisted conception protocolsProtocol breakdown not provided
NotesStudy designed to assess effectiveness of acupuncture as an analgesic
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskDetails not stated
Allocation concealment (selection bias)Low riskAdequate: randomisation using sealed unlabelled envelopes containing a study number
Blinding (performance bias and detection bias)
All outcomes
Low risk‘doctors and patients are blinded to the arm of treatment’.
Incomplete outcome data (attrition bias)
All outcomes
Low risk160 participants randomized; 8 in total withdrew from the study.
Selective reporting (reporting bias)Unclear riskLBR not a prestated outcome
Other biasLow riskNone known

Madaschi 2010

MethodsRandomised controlled trial of fertility patients in Brazil
Participants416 patients stratified according to age and then randomised to either acupuncture group (n = 208) or control with no acupuncture (n = 208)
Interventions

Needle acupuncture 25 minutes before and after embryo transfer versus no acupuncture control. Intervention performed by the same practitioner in all cases

There was no statistically significant difference between the two groups for demographic characteristics. The average age (± SD) in the acupuncture group was 35.3 (± 4.7) compared to 34.6 (± 4.6) in the control group (p = 0.103). The average BMI in the acupuncture group was 22.4 (± 3.8) compared to 22.4 (± 2.9) in the control group (P = 0.951)

The main causes of subfertility were ovarian disorders and male factor with no statistical significance between both groups for any cause of subfertility

OutcomesPregnancy rate, implantation rate, abortion rate and live birth rate
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk‘patients were randomized before the beginning of the ovarian stimulation according to computer generated randomized numbers ‘
Allocation concealment (selection bias)Unclear riskmethod of allocation concealment not reported
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had no treatment. It was not stated if the clinicians or the assessors of the study were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk416 participants were randomized; no drop out noted.
Selective reporting (reporting bias)Unclear riskLBR not a prestated outcome.
Other biasLow riskNone

Moy 2011

MethodsRandomized controlled trial of fertility patients in US
Participants

160 patients undergoing IVF ± ICSI were randomised to either true acupuncture (n = 87) or sham acupuncture (n = 74)

The average age (± SD) in the true acupuncture group was 33.3 (± 0.307) years compared to 33.16 (± 0.334) years in the sham acupuncture group. There was no statistically significant difference in BMI or infertility diagnosis between the two groups, with the leading causes of infertility being male factor, ovarian dysfunction and unexplained.

InterventionsTrue (needle) acupuncture performed by hospital employed licensed acupuncturists versus sham placebo acupuncture. Both interventions performed for 25 minutes before and after embryo transfer
OutcomesClinical pregnancy rate and clinical symptoms during embryo transfer
Assisted conception protocolsProtocol breakdown not provided
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskpatients were randomized using a ‘random number generator’
Allocation concealment (selection bias)Low riskUse of 'sealed, sequentially numbered, opaque envelopes’.
Blinding (performance bias and detection bias)
All outcomes
Low riskControl group was allocated to Sham acupuncture. The physicians and patients were blinded to the randomization until the conclusion of the study.
Incomplete outcome data (attrition bias)
All outcomes
Low risk160 participants were randomized; 1 lost to follow up
Selective reporting (reporting bias)Unclear riskLBR outcome data not reported.
Other biasLow riskNone

Paulus 2002

MethodsRandomised controlled trial in fertility clinic in Germany
Participants

160 patients randomised: 80 to treatment and 80 to no intervention control.

The age of the women (± SD) in the control group (n = 80) was 32.1 years (± 3.9) compared to 32.8 years (± 4.1) in the acupuncture group (n = 80). In the control group the average number of previous cycles was 2.0 (± 2.0) versus 2.1 (± 2.1) in the treatment group.

Most women had tubal disease, followed by male factor infertility then polycystic ovarian disease. These were in equal portions in both the study and control groups.

InterventionsAcupuncture performed by "well-trained examiners" 25 min before and after embryo transfer for treatment group; auricular acupuncture also performed on the treatment group
OutcomesClinical pregnancy rates
Assisted conception protocolsProtocol breakdown not given
NotesSame authors as Paulus 2003 but different group of patients
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer generated randomisation
Allocation concealment (selection bias)Unclear riskNot stated how the allocation was carried out.
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had no treatment. Not stated if clinicians or assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk160 randomised; no drop out.
Selective reporting (reporting bias)Unclear riskNot known whether LBR a prestated outcome
Other biasLow riskNone

Paulus 2003

MethodsRandomised placebo-controlled trial; abstract only
Participants

Patients were divided into two groups by random selection: embryo transfer with verum acupuncture (n = 100) and embryo transfer with placebo needling (n = 100).

No demographic details presented

InterventionsAcupuncture or sham acupuncture performed for 25 minutes before and after embryo transfer. In the control group (n=100) a placebo needle set was used without penetrating the skin, but at the same acupoints and after the same scheme
OutcomesClinical pregnancy rates
Assisted conception protocolsProtocol breakdown not given
NotesOnly included women with good embryos
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskcomputer generated randomisation
Allocation concealment (selection bias)Unclear riskAbstract only, not stated
Blinding (performance bias and detection bias)
All outcomes
Low riskControl group had placebo needling.
Incomplete outcome data (attrition bias)
All outcomes
Low risk100 participants were randomized. No drop out reported.
Selective reporting (reporting bias)Unclear riskNot known whether LBR a prestated outcome
Other biasLow riskNone

Sator-K 2006

MethodsRandomised controlled trial in fertility clinic in Austria
Participants

Patients were randomised in proportions of 1:1:1 to treatment with electro-acupuncture (n = 32), auricular acupuncture without electrical stimulation (n = 32) or a control group without needles or electrical stimulation (n = 30).

The mean ages (± SD) of the women undergoing IVF treatment in the group receiving electro-acupuncture with remifentanil (EA), acupuncture with remifentanil (A), and remifentanil with placebo (CO) were 33.3 years (± 1.7), 34.2 years (± 1.1) and 33.9 years (± 1.9), respectively. There were no differences in the number of failed cycles or causes of subfertility.

InterventionsEA, or EA with electrical stimulation or control of conventional analgesia (remifentanil) at the time of oocyte retrieval
OutcomesPain intensity and subjective well being were assessed using a visual analogue scale Nausea and tiredness were also assessed using a visual rating scale
Analgesic drug requirements during the entire study period
Assisted conception protocolsProtocol breakdown not provided
Notes

Study designed to assess effectiveness of acupuncture as an analgesic

Each P-Stim™ was programmed by an independent technician for electrical stimulation or no stimulation before the study. To ensure blinding of the investigator, each P-Stim™ was packed in a non-transparent case in which the respective permanent needles or adhesive tapes were also included. The packages were numbered consecutively, according to the randomisation list. Patients and investigators were blinded to the randomisation

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskcomputer generated sequence randomisaton
Allocation concealment (selection bias)Unclear risk‘Randomisation was concealed until at least 30 patients were randomized.’ ‘Patients and investigators were blinded to the randomisation’. Method of allocation concealment not clearly reported
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had traditional I.V. pain relief.
Incomplete outcome data (attrition bias)
All outcomes
Low risk94 were randomized. 1 drop out.
Selective reporting (reporting bias)Unclear riskLBR outcome not reported.
Other biasLow riskNone known

Smith 2006

MethodsRandomised controlled trial in fertility clinic in Australia
Participants

228 randomised, 36 excluded: 110 in treatment group and 118 in control group.

The average age of the control group (± SD) was 35.9 years (± 4.7) versus 36.1 years (± 4.8) in the study group; there were no differences in the number of previous treatment cycles, BMI, duration of subfertility.

InterventionsAll women had 3 sessions: day 9 of stimulation, immediately before ET, and immediately after ET. For the sham acupuncture group a sham needle was used close to but not on the treatment point
OutcomesClinical pregnancy rates
Assisted conception protocolsProtocol breakdown not provided
NotesAfter 3rd session, 24 in treatment group and 10 in control group guessed their allocation group correctly
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk‘randomization was in balanced, variable blocks of random size prepared by a researcher not involved in the trial’.
Allocation concealment (selection bias)Unclear riskNot stated specifically
Blinding (performance bias and detection bias)
All outcomes
Unclear riskControl groups had placebo needles (Streitberger) although after the 3rd session, 24 in the treatment group and 10 in the control group guessed their allocation group correctly.
Incomplete outcome data (attrition bias)
All outcomes
High risk228 subjects were randomized. 36 women had to be withdrawn (15%).
Selective reporting (reporting bias)Unclear riskLBR data not reported.
Other biasLow riskNone known

So 2009

MethodsRandomised controlled trial of fertility patients in Hong Kong
Participants

370 patients undergoing assisted reproductive treatment randomised to either acupuncture (n = 185) or placebo acupuncture arms (n = 185).

The median age (interquartile range) in the acupuncture and placebo groups respectively was 36 (33 - 38) and 36 (34 - 38). Mean BMI (± SD) was similar at 21.6 (± 2.1) and 21.7 (± 2.7) kg/m2 for acupuncture and placebo groups respectively.

Both groups were comparable in terms of duration of infertility, cause of infertility, previous experience of acupuncture and smoking habit

InterventionsNeedle acupuncture or placebo needle acupuncture for 25 minutes before and after embryo transfer. Intervention performed by a certified Chinese acupuncturist with a degree in Chinese Medicine and 3 years experience
OutcomesPregnancy rate, clinical pregnancy rate, live birth rate, miscarriage rate
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskParticipants were randomized by a computer generated randomization list
Allocation concealment (selection bias)Low riskSealed opaque envelopes from the list used. ‘The sequence of randomization was concealed until interventions were assigned.’
Blinding (performance bias and detection bias)
All outcomes
Low risk‘patients, clinical staff involved in the care of patients and embryologist were blinded to the treatment group assigned’. The codes were only revealed after the completion of the entire study. Control group also had placebo needles.
Incomplete outcome data (attrition bias)
All outcomes
Low risk370 participants randomized; all completed the study.
Selective reporting (reporting bias)Low riskNone known.
Other biasLow riskNone known

So 2010

MethodsRandomised controlled trial of fertility patients undergoing frozen embryo transfer in Hong Kong
Participants

226 patients randomised to either real (n = 113) or placebo acupuncture (n=113).

The median age at thawing was 36 (34 - 38) and 36 (34 - 39) years for real and placebo acupuncture respectively. The BMI, duration and cause of infertility and previous experience of acupuncture were also comparable between the two groups.

InterventionsNeedle acupuncture according to TCM principles or placebo acupuncture with Streitberger's sham placebo needles. Intervention performed by a certified Chinese acupuncturist with a degree in Chinese Medicine and 3 years experience
OutcomesOverall pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, live birth rate
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
NotesMore patients in placebo group correctly guessed their randomisation compared to the true acupuncture group
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskparticipants were randomized by a computer generated randomization list
Allocation concealment (selection bias)Low riskSealed opaque envelopes from the list was used. ‘The sequence of randomization was concealed until interventions were assigned.’
Blinding (performance bias and detection bias)
All outcomes
Low risk‘patients, clinical staff involved in the care of patients and embryologist were blinded to the treatment group assigned’. The codes were only revealed after the completion of the entire study. Control group also had placebo needles.
Incomplete outcome data (attrition bias)
All outcomes
Low risk226 participants randomized. All completed the study.
Selective reporting (reporting bias)Low riskLBR available.
Other biasLow riskNone known

Stener-Victorin 1999

MethodsRandomised controlled trial, conducted in Sweden
Participants

150 women undergoing IVF and ET were randomised to receive either electro-acupuncture and a paracervical block or alfentanil analgesia and a paracervical block.

The mean ages (range) of the study and control groups were 33.3 years (25 to 42) and 34.4 years (25 to 46). There was no difference in the two groups in terms of the cause of subfertility and the number of previous cycles.

InterventionsAcupuncture was performed at least 30 min before oocyte aspiration and PCB was placed at the start of the procedure and terminated directly after oocyte aspiration
OutcomesVAS, level of stress, implantation and pregnancy rates
Assisted conception protocolsProtocol breakdown not provided
NotesStudy designed to assess effectiveness of acupuncture as an analgesic
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Each centre randomized its patients using sealed, unlabelled envelopes" - no further details
Allocation concealment (selection bias)Unclear risk‘sealed unlabelled envelope’
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had traditional analgesia and t (Alfentanil + para cervical block) therefore blinding nor possible for clinicians or participants.
Incomplete outcome data (attrition bias)
All outcomes
Low risk150 women were randomized. 1 drop out.
Selective reporting (reporting bias)Unclear riskLBR data not reported.
Other biasUnclear risk"There is a possible bias in the study in that some of the women in the EA group were administered additional alfentanil during oocyte aspiration."

Stener-Victorin 2003

MethodsRandomised, controlled multi-centre trial in Sweden
Participants

Women were randomised to either electro-acupuncture and a paracervical block or alfentanil and a paracervical block, as analgesia at the time of oocyte retrieval.

The mean age (range) in the study group was 32.9 years (22 to 38) and for the control group it was 32.9 years (25 to 38). The causes of infertility and number of IVF attempts did not differ between the two groups.

InterventionsWomen were given EA and a PCB of lidocaine hydrochloride during oocyte aspiration. Those women randomised to the alfentanil group were given alfentanil and a PCB during oocyte aspiration. The acupuncture stimulation began at least 30 min before oocyte aspiration
Outcomes

VAS were used for pain assessment

Other variables recorded included abdominal pain, pain during placement of PCB, time of discomfort, adequacy of analgesia, stress level, nausea.

IVF outcomes were pregnancy rate (number of pregnancies per embryo transfer), implantation rate (number of gestational sacs per number of transferred oocytes) and on-going pregnancies (number of pregnancies per embryo transfer after the 16th week of gestation)

Assisted conception protocolsProtocol breakdown not provided
NotesStopped after interim analysis as results show no difference between two groups. Study designed to assess effectiveness of acupuncture as an analgesic
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risknot stated
Allocation concealment (selection bias)Unclear risk‘sealed unlabeled envelopes’
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had paracervical block + Alfentanil and therefore blinding nor possible for clinicians or participants.
Incomplete outcome data (attrition bias)
All outcomes
Low risk286 randomized; 5 in the acupuncture group and 7 in the control group dropped out.
Selective reporting (reporting bias)Unclear riskNot known whether LBR a prestated outcome
Other biasLow riskNone

Westergaard 2006

MethodsRandomised controlled trial with patients from private clinic in Denmark
Participants

273 women randomised: 87 allocated to no acupuncture and 95 to acupuncture on ET day only; 91 to acupuncture on ET and ET+2 days; 27 excluded,

The average ages of the three groups of women were: 37 years (27 to 45) in the control (n = 87) group, 37 years (24 to 45) in the group who had acupuncture on the day of ET (n = 95), and 37 years (27 to 45) for those with repeated acupuncture (ET + 2) (n = 91). There was no difference in the BMI between the three groups and about 67% of women had one or more attempts of IVF in the three groups.

The main causes of subfertility were described as male factor or unexplained

InterventionsAcupuncture was performed by specially trained nurses on patients undergoing ET on the day of ET, ET+2 and not on controls
OutcomesClinical pregnancy rate on ultrasound
Assisted conception protocolsStandard, long protocol GnRH down-regulation and the follicle stimulating hormone (FSH) or human menopausal gonadotrophin (hMG)
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation procedure handled by nurse not involved in study
Allocation concealment (selection bias)Unclear risk‘drawing of sealed envelope’ - no further details reported
Blinding (performance bias and detection bias)
All outcomes
High riskControl group had paracervical block, so blinding of the participants and personnel not possible.
Incomplete outcome data (attrition bias)
All outcomes
Low risk300 participants randomized. 27 dropped out leaving 273 participants for analysis.
Selective reporting (reporting bias)Unclear riskLBR data not prestated outcome.
Other biasLow risknone

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Chen 2004No reply to written and electronic request; study design, allocation concealment and outcomes unclear
Chen 2009No reply to electronic request; study design, methods and results not known
Chen 2012No outcomes of interest
Cui 2007No reply to electronic request; study design, methods and results not known
Cui 2011Inadequate randomisation process in study design, based on odd and even numbers
Evans 2005Lack details on pregnancy outcome, study design, allocation concealment and type of randomisation; no reply to written or electronic letters
Feliciani 2011No reply to electronic request; study numbers, randomisation process and outcomes unclear
Li 2009No reply to electronic request; study design, methods and results not known
Omodei 2010No reply to electronic request; study design, allocation concealment and outcomes unclear
Quintero 2004Lacks details on allocation concealment and randomisation, no reply to requests for details; crossover design

Characteristics of ongoing studies [ordered by study ID]

ACTRN12611000226909

Trial name or titleAcupuncture compared to sham acupuncture and standard care to improve live birth rates for women undergoing IVF: a randomised controlled trial
MethodsParallel design, randomised controlled trial
ParticipantsWomen aged less than 43 years, undergoing a fresh IVF or ICSI cycle, and restricted to women with the potential for a lower live birth rate defined as > 2 previous unsuccessful embryo transfers (fresh or frozen), and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria
InterventionsNeedle or sham acupuncture for 1 hr on day 6-8 of the IVF cycle, plus two treatments on the day of the embryo transfer, 30 minutes before and after embryo transfer. Compared to no treatment control
Outcomes

Primary outcome: live birth - defined as the delivery of one or more living infants, greater than 20 weeks gestation or 400 grams or more birth weight.

Secondary outcomes:

1. clinical pregnancy defined as demonstration of fetal heart activity on ultrasound scan

2. miscarriage defined as a non viable pregnancy prior to 12 weeks gestation

3. quality of life

4. self efficacy

Starting dateRegistration: 02/03/2011
Contact information

Caroline Smith

Centre for Complementary Medicine Research University of Western Sydney Locked Bag 1797 Penrith South DC NSW 2751, Australia

Notes 

IRCT201011275181N4

Trial name or titleEffects of acupuncture on outcome of in vitro fertilization and intracytoplasmic sperm injection (IVF/ICSI) in women with polycystic ovarian -
MethodsParallel design, triple blind, randomised controlled trial
ParticipantsInclusion criteria: women with the diagnosis of PCO (Rotterdam criteria) admitted to the clinic for IVF or ICSI treatments of infertility
InterventionsIntervention group 1: acupuncture based on Traditional Chinese Medicine, 5 sessions of thirty minutes. Intervention 2: Control group: (placebo) the same needles are used in 5 sessions of thirty minutes
Outcomes

Primary outcomes:

Embryo quality. Timepoint: 2 days after embryo transfer. Method of measurement: diagnosed by Embryologist and with embryological criteria.

Oocyte fertilisation rate. Timepoint: first day after embryo transfer. Method of measurement: diagnosed by embryologist and with embryological criteria

Oocyte metaphase 2. Timepoint: before and after embryo transfer. Method of measurement: diagnosed by embryologist and with embryological criteria

Secondary outcomes:

Biochemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: B-hCG

Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: sac observed in vaginal sonography

Miscarriage. Timepoint: <12 weeks after embryo transfer. Method of measurement: vaginal sonography

Take home baby. Timepoint: 9 months after embryo transfer. Method of measurement: Delivery

Starting dateRegistration 13/04/2011
Contact information

Rashidi Batool

Address:

Tehran University of Medical Sciences, Valieasr Hospital and Imam Khomeini Hospital

Tehran

Islamic Republic of Iran

Notes 

NCT00317317

Trial name or titleThe Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients
MethodsParallel design, single-blinded randomised controlled trial
Participants

Inclusion criteria:

- Undergoing in vitro fertilisation protocol (both IVF and intracytoplasmic sperm injection - ICSI)

- Acupuncture naive

- Basal FSH <10

- Minimum age 21 years

InterventionsAcupuncture
Outcomes

Primary outcome: Clinical pregnancy rate

Secondary outcomes:

- B-endorphin levels

- Miscarriage rate

- Stress measurement

- Take home baby rate

Starting dateRegistration: 20/06/2006
Contact information

Grant Zhang, Ph.D.

Center For Integrative Medicine, University of Maryland

Notes 

NCT01449396

Trial name or titleChinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer
MethodsParallel design, double-blinded, randomised controlled trial
Participants

Inclusion criteria:

- 18 to 35 years old

- BMI 20-25

- Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility

- No previous in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments

- No previous experience of acupuncture treatments

- Make cause of sterility

- At least one high quality embryo on the day of uterine transfer

InterventionsAcupuncture versus bed rest
Outcomes

Primary outcome: pregnancy rate

Secondary outcomes:

- Analysis of the results of assisted reproductive cycle

- Determination of serum prolactin and 24h urine cortisol

- Endometrial vascularisation study

- Rating preconceived ideas about acupuncture

Starting dateRegistered: 04/10/2011
Contact information

Monica Romeu

romeu_monvil@gva.es

Notes 

NCT01608048

Trial name or titleTranscutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
MethodsSingle blind RCT
ParticipantsWomen undergoing IVF
InterventionsTranscutaneous electrical acupoint stimulation vs no acupuncture
OutcomesLive birth, clinical pregnancy
Starting dateMay 2012
Contact informationCui Hong Zheng, Doctor ph: 86-27-83663275 email: 635342693@qq.com
Notes 

Ancillary