Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

July 29, 2011 updated by: Cairo University

Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • 35 Eleshreen st. King Faisal.
      • Giza, 35 Eleshreen st. King Faisal., Egypt, 12111
        • Ahmed Elgazzar hospital , Assisted conception unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Hydrosalpinx needle aspiration
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 .
Procedure: ultrasound guided aspiration of hydrosalpingeal fluid
Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
Other Names:
  • ultrasound guided Hydrosalpinx needle aspiration
No Intervention: 2. no aspiration
IVF-ET is done without prior aspiration of hydrosalpingeal fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
Time Frame: 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
5 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .
Time Frame: 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 .
18 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Ahmed Elgazzar Hospital

Investigators

  • Study Chair: Usama M Fouda, M.D, PhD, Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
  • Study Director: Ahmed M sayed, MD,PhD, Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (Estimate)

December 29, 2009

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hydrosalpinx1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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