Trial | NCT00575302  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    follitropin alfa ...

  • Study Participants

    400
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.
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 Started
Dec 31
2007
Primary Completion
Dec 31
2009
Anticipated
Study Completion
Dec 31
2009
Anticipated
Last Update
Apr 13
2010
Estimate

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

300 Active Comparator

administration of 300 IU Gonal-f® in a short agonist protocol.

450 Experimental

administration of 450 IU Gonal-f® in a short agonist protocol.

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
No Results Posted