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

Last updated: March 10, 2025
Sponsor: Fundación Santiago Dexeus Font
Overall Status: Active - Recruiting

Phase

3

Condition

Reproductive Health

Treatment

150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger

150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5

Clinical Study ID

NCT06134479
FSD-SEQ-2023-09
2023-506162-31
  • Ages 18-40
  • Female

Study 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 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 Criteria

Inclusion

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

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 significantconcurrent medical condition that could compromise subject safety or interfered withthe trial assessment).

Study Design

Total Participants: 194
Treatment Group(s): 2
Primary Treatment: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger
Phase: 3
Study Start date:
December 12, 2023
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.