Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

April 12, 2010 updated by: Centre Hospitalier Chretien
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:

300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.

Patient can be eligible for several cycles in same protocol.

Study Type

Interventional

Enrollment (Anticipated)

400

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

  • Belgium
      • Brussels, Belgium, 1000
        • CHU Saint-Pierre
      • Brussels, Belgium, 1180
        • IMEC
      • Gent, Belgium, 9000
        • UZ Gent
    • Liège
      • Rocourt, Liège, Belgium, 4000
        • CHC Saint-Vincent

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

38 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
  • Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
  • Patient can be eligible for several cycles in same protocol.

Exclusion Criteria:

  • Patients who already received doses > 225 IU
  • Patients older than 42 years
  • Patients with basal FSH concentrations ≥ 15 mU/ml at day 3

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: 300
administration of 300 IU Gonal-f® in a short agonist protocol.
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 300 U
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 450 U
Experimental: 450
administration of 450 IU Gonal-f® in a short agonist protocol.
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 300 U
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 450 U

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of mature oocytes
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: 1 month
1 month
follicular development
Time Frame: 1 month
1 month
fertilization rate
Time Frame: 1 month
1 month
embryo quality
Time Frame: 1 month
1 month
pregnancy rate
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Chretien

Collaborators

EMD Serono

Investigators

  • Principal Investigator: Annick Delvigne, PhD, CHC Saint-Vincent

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, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 300 versus 450

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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