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

Cairo University (CU)

Status: Completed

Conditions: Hydrosalpinx

Treatments: Procedure: Hystroscopic proximal tubal occlusion; Procedure: Laparoscopic salpingectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04335864

Hydrosalpinx and ICSI

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Group A

Active Comparator group

Description:

39 patients with hydrosalpinx will have laparoscopic salpingectomy

Treatment:

Procedure: Laparoscopic salpingectomy

Group B

Active Comparator group

Description:

39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Treatment:

Procedure: Hystroscopic proximal tubal occlusion