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

Recruiting
18 - 40 years of age
Female
Phase 3

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Overview

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.

Eligibility

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).

Study details

Fertility

NCT06134479

Fundación Santiago Dexeus Font

25 January 2024

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