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

Hydrosalpinx Clinical Trial

Official title:

A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335864
• Other study ID #: Hydrosalpinx and ICSI
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 15, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrosalpinx

Intervention

Procedure:
• Laparoscopic salpingectomy
39 patients with hydrosalpinx will have laparoscopic salpingectomy
• Hystroscopic proximal tubal occlusion
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Locations

Country	Name	City	State
Egypt	Kasr Alainy hospital-cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate following ICSI	Defined as positive qualitative bhcg(beta human chorionic gonadotropin)	14 days after Embryo transfer
Secondary	Ongoing pregnancy following ICSI	Defined as positive fetal heart rate on ultrasound at 8weeks gestation	8 weeks after Embryo transfer