Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI

Not Applicable

Completed

• Conditions: Hydrosalpinx
• Interventions: Procedure: Laparoscopic salpingectomy; Procedure: Hystroscopic proximal tubal occlusion

• Registration Number: NCT04335864
• Lead Sponsor: Cairo University

Brief Summary

Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Detailed Description

Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.

The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.

The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.

This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

Study Timeline

• Study First Submitted: 2020-03-29
• Study Start: 2020-04-01
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-27
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• primary or secondary infertility cases
• unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

Exclusion Criteria

• Uterine factor of infertility
• male factor of infertility
• preexisting ovarian pathology
• Presence of septic focus
• medical or surgical conditions that contraindicated pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Laparoscopic salpingectomy	39 patients with hydrosalpinx will have laparoscopic salpingectomy
Group B	Hystroscopic proximal tubal occlusion	39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate following ICSI	14 days after Embryo transfer	Defined as positive qualitative bhcg(beta human chorionic gonadotropin)

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy following ICSI	8 weeks after Embryo transfer	Defined as positive fetal heart rate on ultrasound at 8weeks gestation

Trial Locations

Locations (1)

Kasr Alainy hospital-cairo University; 🇪🇬 Cairo, Egypt