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

Phase 3

Recruiting

• Conditions: Fertility
• Interventions: Drug: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger; Drug: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5

• Registration Number: NCT06134479
• Lead Sponsor: Fundación Santiago Dexeus Font

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-18
• Study Start: 2023-12-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150μg CFA at SD 1 following by rFSH 200IU daily from SD 8	150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger	-
150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5	150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5	-

Primary Outcome Measures

Name	Time	Method
Number of MII oocytes retrieved	Trough study completion, an average of 10-20 days.	Number of MII oocytes retrieved

Secondary Outcome Measures

Name	Time	Method
Total number of oocytes retrieved	Trough study completion, an average of 10-20 days.	Total number of oocytes retrieved
FSH	Up to oocyte pickup, an average of 10-20 days.	Endocrine profile FSH
LH	Up to oocyte pickup, an average of 10-20 days.	Endocrine profile LH
PROGESTERONE	Up to oocyte pickup, an average of 10-20 days.	Endocrine profile PROGESTERONE
Estradiol	Up to oocyte pickup, an average of 10-20 days.	Endocrine profile Estradiol
OHSS	Until 15 days after day of oocyte pick-up	Incidence of OHSS
FertiQoL	from stimulation day 1 until the day of oocyte pick-up,10-20 days after the beggining of the stimulation.	Quality of life questionnaire "FertiQoL"
Length of stimulation	up to 18 days	Total days of stimulation
Adverse events	up to 20days	Frequency of adverse events

Trial Locations

Locations (1)

Hospital Universitario Quiron Dexeus; 🇪🇸 Barcelona, Spain