The pathogenesis of infertility is multi-factorial; investigative and treatment approaches should therefore be individualised.
There are many tests for tubal patency with their relative usefulness, but none address all aspects of tubal function.
There is often a clear need for in vitro fertilisation (IVF) in the management of infertility.
This article reviews the current best available evidence and provides an expert insight on the role of tubal patency tests in the era of assisted reproductive techniques (ART).
To understand the relative advantages and limitations of laparoscopy, hysterosalpingogram, hysterosalpingo contrast sonography, selective salpingography and tubal catheterisation, trans-vaginal hydrolaparoscopy, salpingoscopy and fertiloscopy as tests for tubal patency.
To understand the role of Chlamydia trachomatis serology in tubal patency testing.
To evaluate the role of tubal patency test in the hierarchy of investigations for infertility.
To understand the role of tubal surgery in modern management of infertility.
To understand the importance of medical history taking in infertility.
Counselling patients about benefits and risks of tests, surgery and need for assisted conception.
Should primary care trusts fund tubal surgery in patients who are not otherwise eligible for IVF?
There may be psychosocial issues or anxiety so a multidisciplinary approach is important.
The life-time incidence of infertility is widely reported to be 17% (1 in 6 couples); however, the incidence and prevalence has been shown to vary significantly depending on the population studied and methodology used to define infertility. Nevertheless, there is a clear year-on-year increase in the demand for artificial reproductive technology (ART) particularly in-vitro fertilisation (IVF).
IVF was primarily developed as an alternative to surgery for the treatment of tubal factor infertility. However, its superior success even in the presence of severe tubal disease and safe repeatable use on an outpatient basis has led to it replacing tubal surgery in the modern management of infertility.
This article reviews the current best available evidence as well as provide an expert insight on the role of tubal patency tests and tubal surgery in the era of ART.
Tubal patency tests
The availability of a plethora of tests to assess tubal patency suggests that there is no perfect test. The various tests are extensively reviewed in other publications[3-5] and summarised in Table 1.
Laparoscopy is widely considered to be the gold-standard test for tubal patency; however there is no evidence base to support its ‘gold-standard’ attribute due to lack of a proven alternative comparator. As such, the performances of other tests are compared to those of laparoscopy.
Laparoscopy enables a direct visual inspection of the entire external length of the fallopian tube and the pelvis which improves its diagnostic and prognostic ability. Opportunistic treatment of mild/minimal endometriosis and peri-adnexal adhesions confers significant therapeutic benefit.[6, 7] However, it requires general anaesthesia in most cases and is associated with a 0.13% risk of bowel, urological or vascular complications.
Hysterosalpingogram (HSG) is cheap and widely available and due to the longevity of its use, has the largest evidence base to rule out unilateral or bilateral tubal block. It has a low sensitivity of 53% and a high specificity of 87% – i.e. a positive test correctly identifies blocked fallopian tubes in 53% of cases whereas a negative test correctly identifies patent fallopian tubes in 87% of cases. Therefore, given its widespread availability, it is a good screening test to rule out unilateral or bilateral tubal block. Limitations include failed catheterisation or instrumentation and/or incomplete seal around the cervix, false positive due to tubal spasm or debris and reporting errors. The ideal time for the test is menstrual cycle day 7–12 (i.e. after the end of menstruation but before ovulation) and depending on the clinical setting, there can be delays and cancellations due to scheduling problems. Radiation exposure from this is significantly higher than that of a standard chest X-ray and there is a 1–3% risk of pelvic infection.
A recent multicentre prospective cohort study evaluating fecundity rate ratios (FRRs) in 3301 patients who underwent HSG (n =2043), laparoscopy (n =747) or both HSG and laparoscopy (n =511), reported an FRR (95% confidence interval [CI]) of 0.81 (0.59–1.1) for unilateral tubal pathology and an FRR of 0.28 (0.13–0.59) for bilateral tubal pathology at HSG. The FRRs for unilateral and bilateral tubal pathology at laparoscopy were 0.85 (0.47–1.52) and 0.24 (0.11–0.54) respectively. Fecundity rate (FR) represents the probability of spontaneous intrauterine pregnancy (IUP) per time unit elapsed, derived from analysing the cumulative probability of pregnancy over the study duration. Only women trying to conceive are included in the calculation, and women who have conceived using additional treatments are excluded after the start of their additional treatment. FRR is the ratio of fecundity between women with a specific test finding (for example, unilateral or bilateral pathology) and those without the test finding. Therefore, the results of this study, which addressed methodological deficiencies of previous large-scale studies, suggest a 72% reduction in fecundity for HSG and 74% for laparoscopy when the test indicated bilateral tubal pathology. The prognostic ability of unilateral tubal pathology with regard to fecundity for both tests was unclear as the 95% confidence interval crossed the line of unity of no effect.
The use of oil-soluble contrast medium has been shown to confer a therapeutic benefit compared to no intervention (odds ratio [OR] for live birth 2.98 [1.40–6.37]) and water-soluble contrast medium (OR for live birth 1.49 [1.05–2.11]). Despite this, water-soluble medium is preferred due to superior image quality and safety (oil-soluble medium is associated with complications such as oil embolisation and granulomas).
Hysterosalpingo contrast sonography
Hysterosalpingo contrast sonography (HyCoSy) is a transvaginal ultrasound technique in which a water-soluble contrast medium is injected into the uterine cavity using a 5F or 7F catheter. The test is performed in an outpatient setting with the woman in a semi-lithotomy position which allows easier access for cervical catheterisation. HyCoSy allows simultaneous examination of the endometrial cavity, uterine morphology (3D) where available and fallopian tubes while avoiding radiation exposure. Significant technical difficulty may be encountered in obese women and those with acute uterine retroversion and high ovaries.
Data pooled from multiple studies indicate a high sensitivity, specificity, and patient tolerability. On a comparative basis, HyCoSy is more sensitive and specific than HSG;[27, 28, 30] however, one study of 103 women reported a higher likelihood of uncertain (neither patent nor occluded) findings with HyCoSy compared to HSG (8.8% HyCoSy versus 0.5% HSG). Another study reported poor intra-observer reliability (repeat test by same observer after 3 months) for left-sided patency and pathology and offered explanations such as right handedness of the operator and a true finding to explain this statistical anomaly.
A variety of contrast media have been used for HyCoSy – in our experience, the best medium for cavity check is normal saline (saline infusion sonography or SIS) and that for tubal check is hysterosalpingo foam sonography (ExEm® Foam [De Smit Medical Systems, Bristol]).
Selective salpingography and tubal catheterisation
Selective salpingography involves the direct injection of radiopaque dye into the tubal ostium through a catheter introduced transcervical under fluoroscopic control as a result of which it significantly reduces false positives due to tubal spasm and debris. Therefore the test is mainly used second-line to improve the accuracy of HSG or laparoscopy in the diagnosis of proximal tubal obstruction. It also allows direct measurement of tubal perfusion pressures which has been shown to have prognostic value.
Selective salpingography can be combined with tubal catheterisation to treat proximal tubal obstruction. Although successful catheterisation rates are high (62–90%), pregnancy rates are much lower (around 30%). This may be due to re-occlusion or the presence of co-existing inflammatory pathology such as salpingitis isthmica nodosa (SIN) which is best treated by tubal resection and anastomosis (see later). The risk of tubal perforation during catheterisation is 2% and of ectopic pregnancy is 3%. The procedure adds to operator time and radiation exposure to that from a standard HSG. A close working relationship between radiology and fertility teams is necessary for correct interpretation and surgical planning in order to maximise the value of the test. A lack of such working relationships in many clinics due to the challenges inherent to joint working may explain its limited use despite the widespread availability of interventional radiography.
Transvaginal hydrolaparoscopy (THL) involves insufflation of the pelvis with 0.4–0.6 litres of a fluid medium through an insufflating needle inserted into the posterior fornix, followed by the introduction of a small diameter rigid angled endoscope to visualise the pouch of douglas (POD), pelvic side-walls, adnexa and tubal patency (the dye injected transcervically). The test is performed in an outpatient setting under local anaesthetic and minor operative procedures such as ovarian drilling, adhesiolysis, diathermy to endometriosis and salpingostomy can be performed through the operative channel. The single biggest risk is bowel injury, either at the time of insufflation or introduction of the endoscope. Pooled data from large case series (n = 4232) report a recto-sigmoid injury rate of 0.61%, all of which were managed either by primary repair or conservatively with no long-term sequelae. The complication rate is much higher than that observed with laparoscopy and the test is not suitable for women with significant obliteration of POD due to PID, endometriosis and fibroids.
Salpingoscopy is the endoscopic visualisation of the endosalpinx of the tubal infundibulum and ampulla at laparoscopy and/or THL, whereas falloposcopy is the endoscopic visualisation of the whole endosalpinx at hysteroscopy. Although these techniques provide significant additional information, currently there is no universally agreed and validated system to classify normal and abnormal findings and therefore, there is a lack of prognostic ability.
Fertiloscopy is an outpatient technique that combines hysteroscopy, THL and salpingoscopy. A prospective multicentre study (n =92) reported a high degree of concordance between fertiloscopy and laparoscopy. Fertiloscopy was performed first, followed by laparoscopy, by two separate operators chosen by random allocation. Videotape findings of the procedures were reviewed by two other central independent observers to resolve differences. Only 20% of women had normal findings whereas the remainder (80%) had minor abnormalities.
A systematic review and meta-analysis of the available evidence on the association between items reported during medical history taking and tubo-peritoneal pathology reported a strong association for history of complicated appendicitis (OR 7.2, 95% CI 2.2–22.8), pelvic surgery (OR 3.6, 95% CI 1.4–9.0), PID (OR 3.2, 95% CI 1.6–6.6), ectopic pregnancy (OR 16.0, 95% CI 12.5–20.4), endometriosis (OR 5.9, 95% CI 3.2–10.8) and sexually transmitted disease (OR 11.9, 95% CI 4.3–33.3). Women with such a medical background should therefore be offered laparoscopy first-line because of its therapeutic potential.
Chlamydia antibody test
Chlamydia trachomatis is the single largest cause of acquired tubal pathology and evidence of both current and past infection can be easily measured using C. trachomatis antibody test (CAT). The sensitivity (21–90%) and specificity (29–100%) varies depending on the cut-off value used to define a positive result. A recent meta-analysis evaluating the accuracy of three different CAT assays, reported a significantly better performance of MIF (micro-immune-fluorescence) compared to ELISA (enzyme linked immunosorbent assay) or IF (immune-fluorescence) assays.
The optimal cut-off value of CAT should be adjusted as per the individual patient's need; for example, a value that delivers a high sensitivity should be chosen when it is more important to detect tubal pathology with high certainty, whereas a value delivering high specificity should be chosen when it is more important to rule out tubal pathology to avoid unnecessary invasive testing.
Routine or selective use of tubal patency test?
The prevalence of tubal factor infertility varies from 11 to 30% depending on the setting and population;other causes of infertility include male factor (20–30%), anovulation (20%) and unexplained (25–30%). Therefore, the initial investigations of an infertile couple should be confined to assessment of sperm (seminal fluid analysis), pelvic anatomy (transvaginal ultrasound scan), and ovulation and ovarian reserve (follicular phase gonadotrophins, mid-luteal progesterone).
Invasive tubal patency test should be offered after taking into account the overall treatment needs of the woman or couple; the most effective treatment of male factor and long-standing (more than 5 years) unexplained infertility and moderate to severe endometriosis is IVF. Ovulation induction (OI) is the treatment of choice for women with anovulation, whereas, IUI is usually reserved for the treatment of women not exposed to sperm on a regular basis; these include partners with azoospermia, and erectile or ejaculatory dysfunction and single women and same-sex couples. There is strong evidence to suggest that women who are otherwise ovulating and exposed to sperm on a regular basis (unexplained or mild male factor infertility) do not benefit from clomiphene citrate or IUI.
Therefore, invasive tubal testing can be avoided in a vast majority of women, and only offered to those who choose or need OI, IUI or natural conception. In low-risk treatment-naïve women undergoing OI or IUI, we do not advocate the routine use of a tubal patency test prior to initiating treatment. The majority of such women who conceive, do so within the first three attempts and therefore failures beyond this are offered IVF (or FSH therapy if ovulatory failure with clomiphene citrate) and only women keen to proceed with further OI or IUI treatment are offered a tubal patency test. Our current practice is in keeping with data from other studies that confirm a lack of therapeutic and prognostic benefit of routine tubal patency testing prior to initiating IUI in low-risk women.[28, 29]
While there is much debate about the place of tubal patency testing in the infertility work-up and the physician's choice of test, patient choice has not been adequately researched. A recent UK community-based questionnaire study reported women's attitudes towards four tests of tubal patency; laparoscopy, HSG, HyCoSy and fertiloscopy. A total of 68 women, with an average age of 30 years attending a GP surgery in London, were included in the survey and the response rate was 94% (64/68). The majority of women (34%), who were otherwise naïve about these tests and were only informed by means of an information leaflet describing each test, preferred fertiloscopy as first choice due to its ability to visualise the interior of the fallopian tube and the avoidance of general anaesthesia and surgical scars.
Destructive tubal surgery
There is clear evidence of harm to implantation from the presence of hydrosalpinx and therefore surgical treatment of hydrosalpinx, either by salpingectomy or tubal occlusion is now considered standard treatment prior to IVF. The evidence base for this correlates with disease severity and therefore is strongest for ultrasound visible and bilateral disease.[32, 33] There is a theoretical concern of reduced ovarian reserve and responsiveness due to interference in ovarian blood supply following salpingectomy. However, well-designed observational trials have not shown any difference in ovarian responsiveness and egg yield between treated and untreated sides.[34-36]
Routine 2D transvaginal ultrasound has a sensitivity of 84.6% and a specificity of 99.7% for the diagnosis of hydrosalpinx. Therefore, the need to perform tubal patency test to rule out a hydrosalpinx that is not obvious on routine ultrasound examination is debatable and should be reserved for women with recurrent implantation failures despite the transfer of high-quality embryos. Indeed there is strong evidence, albeit without any biological plausibility, of the therapeutic benefit of cavity check by hysteroscopy in women with at least two IVF implantation failures. Therefore the ideal test in women with such a background is HyCoSy which combines cavity check with tubal assessment.
Reconstructive tubal surgery
Tubal pathology is classified as proximal, distal or bipolar (proximal and distal). The indications and success of various tubal surgical interventions are summarised in Table 2.
Table 2. Tubal surgery
Term pregnancy rate [Mean (range)]
Ectopic pregnancy rate [Mean (range)]
Data derived from review Posaci et al 1999. LBR=live birth rate; IVF=in vitro fertilisation; SIN=salpingitis isthmica nodosa.
Hydrosalpinx prior to IVF
(limited data for natural conception)
25% LBR (IVF)
Hydrosalpinx with >50% normal mucosa or bilateral or well informed patient
Reversal of sterilisation
Proximal tubal disease
Proximal tubal disease accounts for approximately 15% of cases of tubal factor infertility; the most common cause is salpingitis isthmica nodosa (SIN), a tubal disease of inflammatory aetiology which is associated with other infective PID stigmata such as distal tubal disease and pelvic and peri-hepatic adhesions. The underlying histopathology reveals endosalpingeal diverticula encased in myosalpingeal hypertrophy and fibrosis resulting in a firm proximal tubular nodule which can be seen on laparoscopic examination (Figure 1). As the disease involves both endosalpingeal and myosalpingeal compartments, it is no surprise that tubal resection and anastomosis (Figure 1) of the diseased inflammatory area results in highest success compared to tubal catheterisation or expectant management irrespective of tubal patency. An endometriotic nodule can mimic SIN – bilateral proximal disease and associated infective PID stigmata are pathognomonic of SIN.
Other known causes of proximal tubal disease include tubal debris and intraluminal adhesions, which are amenable to hysteroscopic or fluoroscopic tubal catheterisation.
Distal tubal disease
Distal tubal disease accounts for approximately 85% of cases of tubal factor infertility. Hydrosalpinx is an end stage of distal tubal disease and is best managed by salpingectomy (Figure 2) followed by IVF. The odds of ongoing pregnancy rate increased two-fold (OR 2.14, 95% CI 1.23–3.73). The presence of bilateral disease, however, raises an ethical dilemma as bilateral salpingectomy renders the woman entirely dependent on IVF for conception. The long-term fertility and psychological impact of such an approach is unquantified and, therefore, management of these women should be individualised based on age, presence of co-aetiologies and the local and personal resources available to fund continued IVF treatments. An interim salpingectomy i.e. salpingectomy after previous failed IVF treatment, confers equivalent benefit to primary salpingectomy and the cumulative birth rate was shown to be similar after a maximum of three completed IVF treatments.
Diseased tubes with a retention of >50% normal mucosa have the best prognosis following reconstructive surgery. Unfortunately, ultrasound criteria do not correlate with endosalpingeal health, although 86% of hydrosalpinges that were visible by ultrasound were found to have severe mucosal damage. Therefore suitability for reconstructive surgery is best assessed at laparoscopy with recourse to salpingoscopy where appropriate.
The exact surgical technique used and the subsequent prognosis depends on the extent and severity of disease; for example greatest success is for salpingo-ovariolysis (division of isolated peri-adnexal adhesions) followed by fimbrioplasty whereas salpingostomy (Figure 2) which is used for treatment of hydrosalpinx is least successful. The main principle of distal tubal surgery is to maximise functional length of the fallopian tube particularly the ampulla by achieving patency as distally and close to the ovary as possible and to suture the margins open where appropriate with the smallest possible diameter non-absorbable suture. The authors prefer 4–0 ProleneTM (Ethicon Inc., Menlo Park, CA, USA) (Figure 2) as it can be used with existing standard laparoscopic needle holders, thus minimising cost of additional equipment.
Reversal of tubal sterilisation
Surgical reversal of tubal sterilisation is just as successful as IVF; however, it is not funded on the NHS (nor is IVF for this patient group). Good prognostic factors include female age <35 years and residual tubal length of more than 4 cm.
Laparotomy versus laparoscopy
The principles of microsurgery include atraumatic surgical technique, magnification, complete excision of disease, precise haemostasis, layered tissue re-anastomosis with non-absorbable material and hydration of exposed tissue surfaces. There are no comparative studies on the performance of laparotomy versus laparoscopic tubal surgery, but there is no underlying reason why microsurgical principles cannot be applied to the laparoscopic approach. The use of robotic surgery with its multiple suturing angles negates the potential mechanical difficulty in achieving optimal tissue anastomosis with standard laparoscopy.
Should PCTs fund reconstructive tubal surgery when the patient is not eligible for IVF?
There is wide variation in the state funding for IVF within the UK, with a majority (90%) of Primary Care Trusts surveyed in 2005 funding one cycle only and none funding the full three cycles recommended by the National Institute for Health and Care Excellence (NICE).[44, 45] While there have been some improvements in equity since the last survey[46, 47] full equitable application of the NICE guideline remains a distant reality.
Local allocation of funds for fertility treatment is based on the founding principles of the NHS i.e. cost-effectiveness (or value for money) and rationing based on treating those at most need. Therefore, a patient not eligible for IVF should not be offered tubal surgery which is equally expensive but far less effective. If an individual funding request (IFR) is deemed appropriate, then it should be for IVF unless there are strong personal or medical grounds to support tubal surgery.
Historically, funded provision of IVF was agreed on the premise that local units ‘switch over’ to IVF rather than continue to offer tubal surgery. This model is flawed at several levels including patient autonomy, safety and effectiveness; for example, a population study published in 1991 where patients were offered a progressive choice of tubal surgery followed by IVF, reported a much higher cumulative success (up to 80%) for the progressive approach[48, 49] than could be achieved by either treatment alone. As surgical techniques have altered very little and IVF technology and success improved significantly since, there is a need to review various models of service delivery and evaluate their efficacy and cost-effectiveness. The modern cost of tubal surgery that can safely be done by a 90-minute day-surgery laparoscopy operation using diathermy scissors, needle holder and non-absorbable sutures is far less expensive than cost calculated based on traditional surgery, which involves inpatient admission for laparotomy microsurgery. The changing landscape of the NHS with commissioning responsibility devolved to local Clinical Commissioning Groups (CCGs) presents a real opportunity to engage commissioners on the role and tariffs for tubal surgery and offer a progressive choice to the patient in this era of ART – to start with, this is best done in units where the local prevalence of tubal factor infertility is high.
In summary, a policy of universal invasive tubal patency testing is to be discouraged; instead the investigation and management of tubal factor infertility should be individualised to the needs of patients and populations. The option of tubal surgery should be explored in selected cases and new models of care provision should be incorporated into the practice where appropriate. Figure 3 presents a pragmatic, evidence-based approach to the management of tubal infertility.