Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (2-Shot)

Fundación Santiago Dexeus Font

Status and phase

Enrolling

Phase 3

Conditions

Fertility

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06134479

FSD-SEQ-2023-09

2023-506162-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

194 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).