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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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300

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

Group Type ACTIVE_COMPARATOR

Gonal-f®: follitropin alpha

Intervention Type DRUG

Gonal-f®: follitropin alpha, administration of 300 U

450

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

Group Type EXPERIMENTAL

Gonal-f®: follitropin alpha

Intervention Type DRUG

Gonal-f®: follitropin alpha, administration of 450 U

Interventions

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Gonal-f®: follitropin alpha

Gonal-f®: follitropin alpha, administration of 300 U

Intervention Type DRUG

Gonal-f®: follitropin alpha

Gonal-f®: follitropin alpha, administration of 450 U

Intervention Type DRUG

Eligibility Criteria

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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.