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

Phase 4
Withdrawn
Conditions
Infertility
Registration Number
NCT00575302
Lead Sponsor
Centre Hospitalier Chretien
Brief Summary

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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
400
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
number of mature oocytes1 month
Secondary Outcome Measures
NameTimeMethod
follicular development1 month
fertilization rate1 month
implantation rate1 month
embryo quality1 month
pregnancy rate1 month

Trial Locations

Locations (4)

CHC Saint-Vincent

🇧🇪

Rocourt, Liège, Belgium

CHU Saint-Pierre

🇧🇪

Brussels, Belgium

IMEC

🇧🇪

Brussels, Belgium

UZ Gent

🇧🇪

Gent, Belgium

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