NCT06134479

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Fundación Santiago Dexeus Font · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fertility

Interventions

Type	Name	Description
DRUG	150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5	On Day 2 or 3 of the menstrual cycle, a first subcutaneous (SC) injection of corifollitropin alfa (CFA) (Elonva®) 150μg will be administered (stimulation day 1) and a second SC injection of corifollitropin alfa (Elonva®) 100 μg will be administrated on SD 5. Endogenous LH suppression will be accomplished by daily 75μg/day of Desogestrel (Cerazet®) per os, at bedtime, starting on stimulation day 1 and continuing up to the day before of trigger. As soon as 3 follicles ≥ 18 mm are observed by ultrasound, 0.2 mg Triptorelin (Decapeptyl®) will be administered the same day to induce final oocyte maturation. About 34-36 hours thereafter oocyte pick-up will be performed.
DRUG	150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger	On Day 2 or 3 of the menstrual cycle, a single subcutaneous (SC) injection of corifollitropin alfa (Elonva®) 150μg will be administered (SD 1) and from Day 8 of stimulation a daily SC dose of rFSH (Puregon®) 200IU/day up to the day of Triptorelin (Decapeptyl®) 0.2 mg administration. Endogenous LH suppression will be accomplished by daily 75μg/day of Desogestrel (Cerazet®) per os, at bedtime, starting on stimulation day 1 and continuing up to the day before of trigger. As soon as 3 follicles ≥ 18 mm are observed by ultrasound, 0.2 mg Triptorelin (Decapeptyl®) will be administered the same day to induce final oocyte maturation. About 34-36 hours thereafter oocyte pick-up will be performed.

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-09-09
• Completion: 2025-09-09
• First posted: 2023-11-18
• Last updated: 2026-02-25

Locations

1 site across 1 country: Spain