Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
Phase 1
- Conditions
- InfertilityTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-004328-73-ES
- Lead Sponsor
- Fundació Privada EUGIn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
-Oocyte donors included in the oocyte donation program of Clinica EUGIN are healthy women younger than 35 years old with normal ovarian reserve.
-1st oocyte donation cycle at Clínica EUGIN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Polycistic Ovarian syndrome (PCOs).
-Estradiol levels on day 2 of menstrual cycle >70 pg/ml.
-Hormone treatments up to 3 months before the oocyte donation cycle.
-Medical contraindication to the treatments used in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the non-inferiority effect, and equal safety, of oral medroxiprogesterone acetate administered orally compared to GnRH antagonist on donor ovarian response.;Secondary Objective: To further evaluate the effect of medroxiprogesterone acetate on hormonal response, inhibition of the luteinizing hormone surge, embryological laboratory outcomes, reproductive outcomes in oocyte recipients and adverse events.;Primary end point(s): -Number of mature oocytes (MII) recovered at oocyte pick-up (OPU).;Timepoint(s) of evaluation of this end point: OPU day
- Secondary Outcome Measures
Name Time Method