Clinical trial
Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.
Name
FSD-SEQ-2023-09
Description
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.
Trial arms
Trial start
2023-12-12
Estimated PCD
2025-09-01
Trial end
2026-01-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5
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.
Arms:
150μg CFA at SD 1 following by rFSH 200IU daily from SD 8
Size
194
Primary endpoint
Number of MII oocytes retrieved
Trough study completion, an average of 10-20 days.
Eligibility criteria
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 194, 'type': 'ESTIMATED'}}
Updated at
2023-12-13
1 organization
2 products
1 indication
Organization
Fundación Santiago Dexeus FontProduct
150μg CFAIndication
FertilityProduct
CFA (Elonva)