Fertility
Conditions
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.
Interventions
DRUG150μg 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.
DRUG150μg 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.
Sponsors
Fundación Santiago Dexeus Font
Organon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes retrieved | Trough study completion, an average of 10-20 days. | Number of MII oocytes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed