Desogestrel (DSG) and Corifollitropin(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. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS. 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. No description of the hormonal and ovarian response under this protocol has been published

Detailed Description
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oral desogestrel since the first menstruation day, a single injection of FSH-CTP on the 7th menstrual cycle day routine monitoring of ovarian response with transvaginal ultrasound every second day until pre-ovulatory bolus of GnRH Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH) Quality of Life questionnaire the day after the bolus

Official Title
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Desogestrel and Corifollitropin Treatment for Ovarian Stimulation in Donors

Conditions
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Infertility

Intervention / Treatment
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* Drug: FSH-CTP + DESOGESTREL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Population: donors (18-35 ) from candidates of Donor program Fulfilling inclusión medical and legal criteria (RD -Ley de transposición de la normativa europea a la legislación española 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSH-CTP + DESOGESTREL<br>Single injection of FSH-CTP and oral desogestrel since the first menstruation day, until bolus of GnRH agonist to follicular maturation | Drug: FSH-CTP + DESOGESTREL<br>* Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH) - Quality of Life questionnaire the day after the bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of gonadotrophins | Total Consume of gonadotrophins | At the end of the stimulation treatment period (5 or 7 days after begining of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LH | Level of LH in plasma (mIU/ml) | Day of GnrH bolus | 
| Number of mature oocytes |  | Day of oocyte recovery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian stimulation, LH inhibition