Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.

Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.

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 and 100μg at SD 5 and 1-shot of CFA administration 150μg at SD 1 following by rFSH 200IU daily from SD 8 in women undergoing elective fertility preservation in a progestin-primed ovarian stimulation (PPOS) protocol and GnRH-agonist (GnRH-a) triggering.

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
• 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 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).