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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation.. The 2-shot Protocol.

Conditions
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Fertility

Intervention / Treatment
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* Drug: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5
* Drug: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 150μg CFA at SD 1 following by rFSH 200IU daily from SD 8<br> | Drug: 150μg CFA (Elonva®) at SD 1 following by rFSH (Puregon®) 200IU daily from SD 8 until the day of the trigger<br>* 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.<br>|
| Experimental: 150μg CFA at stimulation day (SD) 1 and 100μg CFA at SD 5<br> | Drug: 150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MII oocytes retrieved | Number of MII oocytes retrieved | Trough study completion, an average of 10-20 days. | 

Secondary Outcome Measures

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