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Danazol for unexplained subfertility

  • Review
  • Intervention

Authors


Abstract

Background

The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two randomised trials were subsequently conducted to assess the effectiveness of danazol in this population.

Objectives

The objective of this review was to assess the effect of danazol on live birth rate in women with unexplained subfertility.

Search methods

We searched the Cochrane Menstrual Disorders and Sub-fertility Group's specialised register of trials (searched November , 2006) the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), MEDLINE (1966-November 2006), EMBASE (1980 - November 2006) and reference lists of articles.

Selection criteria

Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.

Data collection and analysis

Data were extracted by two reviewers EH and GT.

Main results

Two trials involving seventy-one women were included. There was no statistically significant difference in the live birth/ ongoing pregnancy rate between danazol and placebo at the end of treatment (OR 1.16, 95% CI 0.0 to 8.29; p=0.36) or at the end of follow-up (OR 2.41; 95% CI 0.59 to 9.82; p=0.22). There was no significant difference in clinical pregnancies following treatment (OR 0.14, 95% CI 0.01 to 2.26; p=0.17), however there were significantly more clinical pregnancies during the follow-up period in the danazol group compared with the placebo group (OR 3.15, 95%CI 0.98 to 10.10; p<0.05). Multiple side effects were reported.

Authors' conclusions

Available data demonstrate no evidence of the benefit of danazol for unexplained subfertility. Although there is insufficient evidence to be certain of this, the need for contraception during treatment and the adverse effects and costs of danazol, make its use for this problem unwarranted. The increased pregnancy rate in the long term follow-up data may be attributable to additional therapies and did not influence the live birth/ongoing pregnancy data.

Plain language summary

Danazol for treating subfertility

The drug danazol (Danocrine) was the most frequently prescribed medication for endometriosis but has also been tested as a treatment for unexplained subfertility. The review of trials found that there is no evidence that low doses of danazol improve live births/ ongoing pregnancy rates. Other negative factors include adverse effects.

எளியமொழிச் சுருக்கம்

கருவுறாமைக்கு (Subfertility) டெனோஸால் (Danazol) சிகிச்சை

உட்கருப்பையிய புத்து வீச்சுக்கு (endometriosis) பெரும்பாலும் பரிந்துரைக்கப்படும் மருந்தாக டெனோஸால் (Danocrine)உள்ளது, ஆனால் அது காரணம் அறிய முடியாத கருவுறாமைக்கும் சிகிச்சையாக பரிசோதிக்கப்பட்டுள்ளது. பல்வேறு ஆராச்சிகளை கொண்ட இந்த திறனாய்வில், குறைந்த அளவு டெனோஸால் கொடுப்பது கரு உயிரோடு பிறக்கும் அல்லது கர்ப்பம் தரித்திருக்கும் விகிதத்தை மேம்படுத்தும் என்பதற்கான ஆதாரங்கள் கிட்டவில்லை. இதன் பக்கவிளைவுகளை மற்ற எதிர்மறை காரணிகளாக எடுத்துக்கொள்ளலாம். விகிதத்தை கூட்டும் என்பதற்கான ஆதாரம் இந்த திறனாய்வின் முலம் கிட்டவில்லை.

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மொழிபெயர்ப்பு:சி.இ.பி.என்.அர் குழு.

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