Surgical treatment for tubal disease in women due to undergo in vitro fertilisation

Review question

We reviewed the efficacy and safety of performing surgery on women with known disease of the fallopian tube, particularly hydrosalpinx (a condition in which fluid accumulates in one or both fallopian tubes, leading to poor reproductive success), before in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). We aimed to compare all types of surgery on the fallopian tube with no surgery prior to IVF. These types of surgery include salpingectomy, where one or both fallopian tubes are removed; tubal occlusion, where the fallopian tubes are blocked using metal clips or divided with scissors and electrocautery so that the fluid from existing hydrosalpinges does not reach the cavity of the womb; and ultrasound-guided aspiration of the hydrosalpingeal fluid through the vagina. Where evidence was available, we also aimed to compare any type of fallopian tube surgery to any other type of fallopian tube surgery.

Background

Up to one in five women who suffer with infertility are diagnosed with blockage of one or both fallopian tubes. IVF treatment is used for women with tubal disease, as the eggs and sperm are manipulated outside the body. The resulting embryos are transferred back into the cavity of the womb, without the need for open fallopian tubes. However, research has shown that in cases of tubal blockage, women may develop a condition termed hydrosalpinx, where fluid accumulates inside the tubes and may prevent the successful implantation of embryos created by IVF. Tubal surgery has therefore been suggested to treat hydrosalpinges, as it may prevent the hydrosalpingeal fluid from reaching the cavity of the womb. If this fluid reaches the womb cavity, it may negatively affect the success of assisted conception.

Study characteristics

We found 11 randomised controlled trials comparing surgery on the fallopian tube to no tubal surgery in a total of 1386 women with hydrosalpinges prior to IVF. The evidence is current to January 2020.

Key results

No studies reported on live birth rates in the main comparison of tubal surgery versus no tubal surgery. Compared to no surgery in the fallopian tube, salpingectomy probably increases the chance of clinical pregnancy. The evidence suggests that if the chance of clinical pregnancy is assumed to be 19% with no salpingectomy, the chance of clinical pregnancy following salpingectomy would be between 27% and 52%. There was a lack of sufficient data to identify an effect of the different types of tubal surgery on adverse events such as surgical complications, miscarriage and ectopic pregnancy.

Quality of the evidence

Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged from very low- to low-quality. The main limitations in this body of research were the lack of blinding (the process where the women participating in the trial, as well as the research staff, are not aware of the intervention used), inconsistency (differences in results across studies) and imprecision (random error and small size of each study) .

Authors' conclusions: 

We found moderate-quality evidence that salpingectomy prior to ART probably increases the CPR compared to no surgery in women with hydrosalpinges. When comparing tubal occlusion to no intervention, we found that tubal occlusion may increase CPR, although the evidence was of low quality. We found insufficient evidence of any effect on procedure- or pregnancy-related adverse events when comparing tubal surgery to no intervention. Importantly, none of the studies reported on long term fertility outcomes. Further high-quality trials are required to definitely determine the impact of tubal surgery on IVF and pregnancy outcomes of women with hydrosalpinges, particularly for LBR and surgical complications; and to investigate the relative efficacy and safety of the different surgical modalities in the treatment of hydrosalpinges prior to ART.

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Background: 

Tubal disease accounts for 20% of infertility cases. Hydrosalpinx, caused by distal tubal occlusion leading to fluid accumulation in the tube(s), is a particularly severe form of tubal disease negatively affecting the outcomes of assisted reproductive technology (ART). It is thought that tubal surgery may improve the outcome of ART in women with hydrosalpinges.

Objectives: 

To assess the effectiveness and safety of tubal surgery in women with hydrosalpinges prior to undergoing conventional in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).

Search strategy: 

We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, DARE, and two trial registers on 8 January 2020, together with reference checking and contact with study authors and experts in the field to identify additional trials.

Selection criteria: 

Randomised controlled trials (RCTs) comparing surgical treatment versus no surgical treatment, or comparing surgical interventions head-to-head, in women with tubal disease prior to undergoing IVF.

Data collection and analysis: 

We used Cochrane's standard methodological procedures. The primary outcomes were live birth rate (LBR) and surgical complication rate per woman randomised. Secondary outcomes included clinical, multiple and ectopic pregnancy rates, miscarriage rates and mean numbers of oocytes retrieved and of embryos obtained.

Main results: 

We included 11 parallel-design RCTs, involving a total of 1386 participants. The included trials compared different types of tubal surgery (salpingectomy, tubal occlusion or transvaginal aspiration of hydrosalpingeal fluid) to no tubal surgery, or individual interventions to one another. We assessed no studies as being at low risk of bias across all domains, with the main limitations being lack of blinding, wide confidence intervals and low event and sample sizes. We used GRADE methodology to rate the quality of the evidence. Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged between very low- to low-quality.

Salpingectomy versus no tubal surgery

No included study reported on LBR for this comparison. We are uncertain of the effect of salpingectomy on surgical complications such as the rate of conversion to laparotomy (Peto odds ratio (OR) 5.80, 95% confidence interval (CI) 0.11 to 303.69; one RCT; n = 204; very low-quality evidence) and pelvic infection (Peto OR 5.80, 95% CI 0.11 to 303.69; one RCT; n = 204; very low-quality evidence). Salpingectomy probably increases clinical pregnancy rate (CPR) versus no surgery (risk ratio (RR) 2.02, 95% CI 1.44 to 2.82; four RCTs; n = 455; I2 = 42.5%; moderate-quality evidence). This suggests that in women with a CPR of approximately 19% without tubal surgery, the rate with salpingectomy lies between 27% and 52%.

Proximal tubal occlusion versus no surgery

No study reported on LBR and surgical complication rate for this comparison. Tubal occlusion may increase CPR compared to no tubal surgery (RR 3.21, 95% CI 1.72 to 5.99; two RCTs; n = 209; I2 = 0%; low-quality evidence). This suggests that with a CPR of approximately 12% without tubal surgery, the rate with tubal occlusion lies between 21% and 74%.

Transvaginal aspiration of hydrosalpingeal fluid versus no surgery

No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 176). We are uncertain whether transvaginal aspiration of hydrosalpingeal fluid increases CPR compared to no tubal surgery (RR 1.67, 95% CI 1.10 to 2.55; three RCTs; n = 311; I2 = 0%; very low-quality evidence).

Laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy

We are uncertain of the effect of laparoscopic proximal tubal occlusion versus laparoscopic salpingectomy on LBR (RR 1.21, 95% CI 0.76 to 1.95; one RCT; n = 165; very low-quality evidence) and CPR (RR 0.81, 95% CI 0.62 to 1.07; three RCTs; n = 347; I2 = 77%; very low-quality evidence). No study reported on surgical complication rate for this comparison.

Transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy

No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 160). We are uncertain of the effect of transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic salpingectomy on CPR (RR 0.69, 95% CI 0.44 to 1.07; one RCT; n = 160; very low-quality evidence).

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