Tailored Ovarian Stimulation Based on BMI, AMH, AFC

Study Overview
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Brief Summary
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The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC). 300 patients will be randomized in 2 arms: control group: standard care rec FSH. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level. Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used. Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.

Detailed Description
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The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B. 300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms: control group: standard care recFSH based on age, basal FSH and AFC. study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level. FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows: Correction factor for AMH: <1 pMol/L X4 1-6 pMol/L X2 7-18 pMol/L X1 >18 pMol/L X0.5 BMI 16.5-18.5 X0.75 18.5-25 X1 25-30 X1.25 30-35 X1.5 35-40 X2 Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used. Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.

Official Title
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Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC

Conditions
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Infertility

Intervention / Treatment
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* Drug: recFSH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female infertile patients eligible for IVF treatment Exclusion Criteria: polycystic ovaries untreated thyroid pathology hypogonadotropic hypogonadism untreaed hyperprolactinemia study drug hypersensitivity previous OHSS unilateral ovariectomy genital malformation BMI>40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 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 |
| --- | --- |
| Other: control group<br>standard care recFSH | Drug: recFSH<br> <br> * Other names: Fostimon;|
| Experimental: study group<br>modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC | Drug: recFSH<br> <br> * Other names: Fostimon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of mature follicles |  | 2 years | 
| number of oocytes retrieved |  | 2 years | 
| rec FSH dose used |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate |  | 2 years | 
| cleavage rate |  | 2 years | 
| clinical pregnancy rate |  | 2 years | 
| AMH level during stimulation |  | 2 years | 
| Inhibin B level during stimulation |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted