Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

Phase 3

Completed

• Conditions: Blocked fallopian tube filled with fluid; 10010273; 10033283; 10029903

• Registration Number: NL-OMON39635
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Presence of uni- or bilateral hydrosalpinges (established with transvaginal ultrasouns)
- Female age <= 40 years at the time of randomization
- Patient suitable for IVF-ET treatment
- Patient suitable for laparoscopic surgery

Exclusion Criteria

- Female age > 40 years at the time of randomization
- Pregnancy or suspected pregnancy
- Recent or active pelvic infection
- Evidence of proximal tubal occlusion in the hydrosalpinx seen at HSG or at laparoscopy
- Patient not suitable for IVF-ET
- Patient not suitable for laparoscopic surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Live birth rate<br /><br>• Clinical pregnancy rate (defined by the demonstration of fetal heart activity<br /><br>on ultrasound).<br /><br>• Success rate of proximal tubal occlusion with Essure® devices (demonstrated<br /><br>by HSG)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Miscarriage rate<br /><br>• Implantation rate (defined as number of gestational sacs on ultrasound/<br /><br>number of embryo*s transferred)<br /><br>• Ectopic pregnancy rate<br /><br>• Multiple pregnancy rate<br /><br>• Complications rate<br /><br>• Ovarian reserve pre- vs. postsurgery (determined by early follicular serum<br /><br>FSH/AMH as well as antral follicle counts)<br /><br>• Change in endometrial receptivity, determined by<br /><br>endometrial biopsy once before treastment of the hydrosalpinx and the second 12<br /><br>weeks post treatment. Endometrial receptivity will be<br /><br>examined by measuring the gene expression in the biopsies and by<br /><br>histological dating of the biopsies.</p><br>