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

Centre Hospitalier Chretien

Status and phase: Withdrawn; Phase 4

Conditions: Infertility

Treatments: Drug: Gonal-f®: follitropin alpha

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00575302

Study 300 versus 450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 38 to 42 years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

300

Active Comparator group

Description:

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

Treatment:

Drug: Gonal-f®: follitropin alpha

Drug: Gonal-f®: follitropin alpha

450

Experimental group

Description:

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

Treatment:

Drug: Gonal-f®: follitropin alpha

Drug: Gonal-f®: follitropin alpha