Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Phase 2

Completed

• Conditions: Infertility
• Interventions: Procedure: ultrasound guided aspiration of hydrosalpingeal fluid

• Registration Number: NCT01040351
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

Detailed Description

A Cochrane review of prospective randomized 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 and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics 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. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-29
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Results First Submitted: 2010-05-10
• Status Verified: 2010-10
• Results First Submitted QC: 2011-07-29
• Last Update Submitted: 2011-07-29
• Results First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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
1: Hydrosalpinx needle aspiration	ultrasound guided aspiration of hydrosalpingeal fluid	After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle	5 weeks after embryo transfer	The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound; )in a transfer cycle

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .	18 weeks after embryo transfer	The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .

Trial Locations

Locations (1)

Ahmed Elgazzar hospital , Assisted conception unit; 🇪🇬 Giza, 35 Eleshreen st. King Faisal., Egypt