Estrogen Pretreatment Prior to GnRH Antagonist Protocol

December 9, 2011 updated by: Dr CEDRIN-DURNERIN Isabelle, Gemer

Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist

The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

472

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

  • France
    • Ile de France
      • Bondy, Ile de France, France, 93140
        • Service de Medecine de la Reproduction, Hôpital Jean Verdier

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 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • regular normo-ovulatory cycles (28 to 35 days)
  • age < 38 years,
  • body mass index (BMI) between 18 and 30
  • first or second IVF/ICSI attempt

Exclusion Criteria:

  • high basal levels of serum FSH or E2,
  • less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
  • history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt

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: Estrogen pre-treatment
Drug: 17beta-estradiol
Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.
No Intervention: Control
The control group did not receive any pre-treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of retrieved oocytes
Time Frame: at the ovarian puncture, 36 hours post HCG administration
at the ovarian puncture, 36 hours post HCG administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: at pregnancy test and at 6 Week US examination
at pregnancy test and at 6 Week US examination
delivery rate
Time Frame: 9 months later
9 months later
number of obtained embryos
Time Frame: 2 days after in vitro fertilization
2 days after in vitro fertilization
duration of FSH administration
Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration
number of days of administration
at the end of ovarian stimulation usually after a mean of 12 days of administration
Total FSH dose
Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration
daily dose x number of days of administration
at the end of ovarian stimulation usually after a mean of 12 days of administration

Collaborators and Investigators

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

Sponsor

Gemer

Investigators

  • Study Director: Jean Noel Hugues, MD, PhD, Hôpital Jean Verdier
  • Principal Investigator: Isabelle cedrin-durnerin, MD, Hôpital Jean Verdier

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

December 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

December 9, 2011

First Posted (Estimate)

December 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2011

Last Update Submitted That Met QC Criteria

December 9, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2PRETREATMENT

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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