Status:
RECRUITING
Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.
Lead Sponsor:
Fundación Santiago Dexeus Font
Collaborating Sponsors:
Organon
Conditions:
Fertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
This randomized was designed as non-inferiority trial aiming to compare the number of MII oocytes with 2-shot of Corifollitropin alpha (CFA) sequential administration: 150μg at stimulation day (SD) 1 ...
Eligibility Criteria
Inclusion
- 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
- Body weight \> 50 kg for \> 36 years
- Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.
Exclusion
- 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).
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06134479
Start Date
December 12 2023
End Date
January 1 2026
Last Update
November 18 2025
Active Locations (1)
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1
Hospital Universitario Quiron Dexeus
Barcelona, Spain, 08028