Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

Study Overview
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Brief Summary
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Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge. In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response. Other authors have reported good results using similar synthetic progestins (Medroxyprogesterone, dihydrogesterone, and natural progesterone). No description of the hormonal and ovarian response under this protocol has been published. Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily gonadotropins has not been reported.

Official Title
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Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

Conditions
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Controlled Ovaria Stimulation

Intervention / Treatment
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* Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Fulfilling inclusión medical and legal criteria (RD - Spanish law adapting european rule-9/2014) Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections Given signed consent form. Exclusion Criteria: Previous low response to COS Previous ovarian hyperstimulation syndrome. Ovarian cysts.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DSG-CTP<br> | Drug: Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of gonadotrophins | Sum of gonadotrophins dose | At the end of stimulation treatment period (from day of corifollitropin administration until the day of triggering) ) an average 10 days after beginning treatment | 
| Oocyte retrieved | Number of oocyte retrieved | Oocyte retrieval day an average 10 days after beginning treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocyte donors, Ovarian stimulation, Desogestrel, Corifolitropina alfa, Gonadotropins