Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET

Phase 2

Completed

• Conditions: Infertility
• Interventions: Procedure: Needle aspiration of hydrosalpinx; Procedure: Salpingectomy

• Registration Number: NCT02008240
• Lead Sponsor: Aljazeera Hospital

Brief Summary

The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.

Detailed Description

The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .

Cochrane review of prospective randomised trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF-ET outcomes in patients with hydrosalpinges.

Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy . Although these methods are simple and getting popular, current data are inadequate to recommend these treatment options instead of salpingectomy because most of the supporting evidences for these methods come from small retrospective studies.

A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.

The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-12-08
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-11
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
• Age between 18 - 37 years
• Period of infertility > 1 year
• Body mass index between 19-29
• Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations.
• Normal recent semen analysis (according to World Health Organization criteria).

Exclusion Criteria

• Uterine fibroid requiring surgical removal.
• Endometriosis.
• Male factor of infertility requiring ICSI, Previous IVF cycles.
• History of recurrent miscarriage.
• Endocrinologic disorders.
• Presence of systemic disease contraindicating pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Needle aspiration of hydrosalpinx	Needle aspiration of hydrosalpinx	Aspiration of hydrosalpingeal fluid under ultrasound guidance
salpingectomy	Salpingectomy	Surgical removal of hydrosalpinx

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle	5 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .	18 weeks after embryo transfer

Trial Locations

Locations (1)

Aljazeera (Al Gazeera) hospital; 🇪🇬 Giza, Egypt