A randomized controlled trial comparing sequential of two shots of CFA vs CFA + rFSH for Elective Fertility Preservation. The 2-shot protocol.
Phase 1
- Conditions
- InfertilityMedDRA version: 20.0Level: LLTClassification code: 10021930Term: Infertility NOS Class: 10038604Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-506162-31-00
- Lead Sponsor
- Santiago Dexeus Font Fundacio Privada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 194
Inclusion Criteria
AFC = 20, Anti-Mullerian hormone (AMH) = 3ng/ml (AMH result of up to one year will be valid), Between 18 and 40 years old, BMI > 18 and < 30 kg/m2, Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation
Exclusion Criteria
Medically indicated fertility preservation, AFC > 20, Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria, FSH = 20, History of untreated autoimmune, endocrine, or metabolic disorders, Contraindication for hormonal treatment, Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
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