Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor

Study Overview
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Brief Summary
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This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation). This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.

Official Title
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Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study

Conditions
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Ovarian Stimulation

Intervention / Treatment
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* Drug: Time of administration of Corifollitropin Alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for oocyte donation program Age between 18 and 32 years old BMI >18 and <30 Antral follicle count >12 (summing both ovaries) Presence of both ovaries Ability to participate in and comply with study protocol Signed informed consent No treatment with ovulation stimulators in the 3 months prior to the start of stimulation. Exclusion Criteria: Diagnosis of endometriosis at any stage AFC >20 Polycystic ovary syndrome Concurrent participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7-days pill free interval<br> | Drug: Time of administration of Corifollitropin Alfa<br>* The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity. The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.<br>|
| No Intervention: 5-days pill free interval<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes | Number of oocytes after stimulation | At the end of stimulation |