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

Sponsor

Centre Hospitalier Chretien (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00575302

Collaborator

EMD Serono (Industry)

400

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Gonal-f®: follitropin alpha Drug: Gonal-f®: follitropin alpha	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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
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

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

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

Outcome Measures

Primary Outcome Measures

number of mature oocytes [1 month]

Secondary Outcome Measures

follicular development [1 month]
fertilization rate [1 month]
implantation rate [1 month]
embryo quality [1 month]
pregnancy rate [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.