Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger

February 6, 2017 updated by: Osama Saber Thabet Abdalmageed, Assiut University

Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles

Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

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

    • Non-US/Non-Canadian
      • Assiut, Non-US/Non-Canadian, Egypt, 71111
        • Recruiting
        • Osama Abdalmageed

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All antagonist cycle ivf who agree to participate

Exclusion Criteria:

  • expected poor responders.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: -ve arm
The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm)
Omit Citrotide 0.25 dose on the day of triggering of ovulation
No Intervention: +ve arm
The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of retrieved oocytes
Time Frame: One Month
total number and maturation of the retrieved oocytes
One Month

Collaborators and Investigators

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

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.

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 (Actual)

January 1, 2017

Primary Completion (Anticipated)

August 30, 2017

Study Completion (Anticipated)

December 30, 2017

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The regulations in Assiut University do not allow protected patient data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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