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

This study has been withdrawn prior to enrollment.
(36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.)
Sponsor:
Collaborator:
EMD Serono
Information provided by:
Centre Hospitalier Chretien
ClinicalTrials.gov Identifier:
NCT00575302
First received: December 17, 2007
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Gonal-f®: follitropin alpha
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Chretien:

Primary Outcome Measures:
  • number of mature oocytes [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • follicular development [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • fertilization rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • implantation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • embryo quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • pregnancy rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 450
administration of 450 IU Gonal-f® in a short agonist protocol.
Drug: Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha, administration of 450 U

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.

  Eligibility

Ages Eligible for Study:   38 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575302

Locations
Belgium
CHC Saint-Vincent
Rocourt, Liège, Belgium, 4000
CHU Saint-Pierre
Brussels, Belgium, 1000
IMEC
Brussels, Belgium, 1180
UZ Gent
Gent, Belgium, 9000
Sponsors and Collaborators
Centre Hospitalier Chretien
EMD Serono
Investigators
Principal Investigator: Annick Delvigne, PhD CHC Saint-Vincent
  More Information

No publications provided

Responsible Party: Annick Delvigne, CHC Saint-Vincent
ClinicalTrials.gov Identifier: NCT00575302     History of Changes
Other Study ID Numbers: Study 300 versus 450
Study First Received: December 17, 2007
Last Updated: April 12, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Centre Hospitalier Chretien:
IVF
poor responder
recFSH
Fertilization in Vitro
Poor responders

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014