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

PHASE3RecruitingINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

December 12, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

January 31, 2026

Conditions
Fertility
Interventions
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.

Trial Locations (1)

08028

RECRUITING

Hospital Universitario Quiron Dexeus, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Organon

INDUSTRY

lead

Fundación Santiago Dexeus Font

OTHER

NCT06134479 - Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. | Biotech Hunter | Biotech Hunter