Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

Study Overview
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Brief Summary
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To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.

Official Title
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Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors

Conditions
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Oocyte Donation

Intervention / Treatment
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* Drug: Corifollitropin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations Donors can´t have more than 6 children (neither own or after donations) Not be adopted or being born after a gamete donation pregnancy BMI between 18-28 kg/m2 Height > 1.55cm Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype No abnormal Psychological profile Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases. Without psychological/psychiatric family history Will conform to the protocol for the duration of the study Willingness of adhesion to protocol during the whole study period Signed informed consent Exclusion Criteria: Polycystic ovarian syndrome Antral follicle count > 20 Hypersensitivity to the active substance or any of the excipients Abnormal vaginal bleeding of unknown ethiology Presence of ovarian cysts or increased size ovaries History of ovarian hyperstimulation syndrome Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm Previous abdominal surgery that contraindicated the practice of follicular puncture HIV, HCV, HBV positive serology in women or partner Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors…)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day 5<br>Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors. | Drug: Corifollitropin alfa<br> <br> |
| Active Comparator: Day 7<br>Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors. | Drug: Corifollitropin alfa<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dosis of rFSH (IU) |  | donors will be followed until the end of stimulation period, an expected average of 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corifollitropin alfa, Stimulation protocol