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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | standard care recFSH |
|
| study group | Experimental | modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recFSH | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| number of mature follicles | 2 years | |
| number of oocytes retrieved | 2 years | |
| rec FSH dose used | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| fertilization rate | 2 years | |
| cleavage rate | 2 years | |
| clinical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Wyns, MD, PhD | Contact | 003227649501 | christine.wyns@uclouvain.be | |
| Céline Pirard, Md, PhD | Contact | 003227644116 | celine.pirard@uclouvain.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| C571802 | follitropin beta |
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| 2 years |
| AMH level during stimulation | 2 years |
| Inhibin B level during stimulation | 2 years |