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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
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.
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.
Hospital Universitario Quiron Dexeus
Barcelona, Spain
RECRUITINGNumber of MII oocytes retrieved
Number of MII oocytes retrieved
Time frame: Trough study completion, an average of 10-20 days.
Total number of oocytes retrieved
Total number of oocytes retrieved
Time frame: Trough study completion, an average of 10-20 days.
FSH
Endocrine profile FSH
Time frame: Up to oocyte pickup, an average of 10-20 days.
LH
Endocrine profile LH
Time frame: Up to oocyte pickup, an average of 10-20 days.
PROGESTERONE
Endocrine profile PROGESTERONE
Time frame: Up to oocyte pickup, an average of 10-20 days.
Estradiol
Endocrine profile Estradiol
Time frame: Up to oocyte pickup, an average of 10-20 days.
OHSS
Incidence of OHSS
Time frame: Until 15 days after day of oocyte pick-up
FertiQoL
Quality of life questionnaire "FertiQoL"
Time frame: 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
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Time frame: up to 18 days
Adverse events
Frequency of adverse events
Time frame: up to 20days