Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome

April 19, 2016 updated by: Ahmad Hussieny Salama

Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases

The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients.

Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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
      • Cairo, Egypt, 1156
        • Ain Shams University

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. More than 9 days of induction of ovulation.
  2. Each ovary contains more than 20 follicles.
  3. The majority of follicles are >14mm in diameter.
  4. Mild fluid in Douglas pouch.
  5. The patient started to complain of considerable lower abdominal pains before the egg collection.

Exclusion Criteria:

  1. Recurrent ICSI failure or bad obstetric history.
  2. Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 7 eggs collection
Aspiration of 7 eggs only
Procedure: 7 eggs collection
vaginal US
Active Comparator: Full eggs collection
Aspiration of all eggs
Procedure: Full eggs collection
vaginal US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Ahmad Hussieny Salama

Investigators

  • Principal Investigator: Ahmed H Salama, MD, Ain Shams University

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

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 12, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFOHSS

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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