Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

October 30, 2009 updated by: Aristotle University Of Thessaloniki

Fixed Versus Flexible GnRH Antagonist Initiation

This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 4

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

  • Greece
      • Thessaloniki, Greece
        • Unit for Human Reproduction

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 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • < 39 years of age
  • BMI 18.5-29.9
  • <= 3 previous IVF cycles

Exclusion Criteria:

  • PCOS
  • Endometriosis

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
Active Comparator: fixed
Drug: Cetrorelix (Cetrotide)
flexible antagonist administration according to specified criteria
Other Names:
  • Cetrorelix, Cetrotide, Serono
Drug: Cetrorelix (Cetrotide)
fixed antagonist administration on day 6 of ovarian stimulation
Other Names:
  • Cetrorelix, Cetrotide, Serono
Experimental: flexible
Drug: Cetrorelix (Cetrotide)
flexible antagonist administration according to specified criteria
Other Names:
  • Cetrorelix, Cetrotide, Serono
Drug: Cetrorelix (Cetrotide)
fixed antagonist administration on day 6 of ovarian stimulation
Other Names:
  • Cetrorelix, Cetrotide, Serono

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Luteinizing hormone rise
Time Frame: 3-14 days (duration of ovarian stimulation)
3-14 days (duration of ovarian stimulation)

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Efstratios Kolibianakis, Unit for Human Reproduction

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

June 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

November 13, 2007

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 1, 2009

Last Update Submitted That Met QC Criteria

October 30, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHR-3

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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