sefulness of Corifollitropin alfa as alternative to conventional daily rFSH protocols in oocyte donors undergoing pituitary suppression with Medroxiprogesterona acetate (MPA).
- Conditions
- Female infertilityTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-506908-66-00
- Lead Sponsor
- Ivi Valencia S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 318
Signature of subject's informed consent prior to any trial-related activity. - Age between 18 and 35 years (inclusive). - Regular menstrual cycle, 25 to 35 days (both inclusive). - Absence of physical and mental illness at the time of donation at the discretion of the investigator. - BMI 18-28 kg/m2 (both inclusive) at the time of donation. - No personal or family history of interest at the discretion of the investigator. - Normal uterus and ovaries, without organic pathology. - No polycystic ovaries. - Antral follicle count greater than 12 in the sum of the two ovaries at the time of the selection visit. - Normal karyotype. - Negative screening for infectious diseases (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis). - General analysis with haemogram, haemostasis and biochemistry with parameters within normality.
- Concurrent participation in another clinical trial. - Previous participation in this clinical trial. - Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotrophins. - Personal history of thrombophlebitis and thromboembolic phenomena and AHT. - Severe hepatic insufficiency, cardiovascular disease. - Suspicion or evidence of breast or hormone-dependent genital organ malignancy - known hypersensitivity to MPA or its excipients - Use of long-term hormonal contraception (hormonal IUDs or subcutaneous implants) at least 1 month prior to inclusion - Any reason for exclusion from the oocyte donation programme
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method