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

Study Overview
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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.

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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Gonal-f®: follitropin alpha
* Drug: Gonal-f®: follitropin alpha


Participation Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 300<br>administration of 300 IU Gonal-f® in a short agonist protocol. | Drug: Gonal-f®: follitropin alpha<br>* Gonal-f®: follitropin alpha, administration of 300 U<br>|
| Experimental: 450<br>administration of 450 IU Gonal-f® in a short agonist protocol. | Drug: Gonal-f®: follitropin alpha<br>* Gonal-f®: follitropin alpha, administration of 450 U<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mature oocytes |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follicular development |  | 1 month | 
| fertilization rate |  | 1 month | 
| implantation rate |  | 1 month | 
| embryo quality |  | 1 month | 
| pregnancy rate |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, poor responder, recFSH, Fertilization in Vitro, Poor responders