Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

July 5, 2023

Primary Completion Date

March 30, 2024

Study Completion Date

June 30, 2024

Conditions
Ovarian Function InsufficiencyFertility IssuesInfertility,FemaleInfertility
Interventions
DRUG

Follitropin beta injection 150 IU

"Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 150 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time:~* one follicle on the morning of day 5, before the administration of the first GnRH-antagonist~* one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm~* two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation.~Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation."

DRUG

Follitropin beta injection 300 IU

"Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 300 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time:~* one follicle on the morning of day 5, before the administration of the first GnRH-antagonist~* one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm~* two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation.~Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation."

Trial Locations (1)

60202

ART Fertility Clinics LLC, Abu Dhabi

All Listed Sponsors
collaborator

Organon and Co

INDUSTRY

lead

ART Fertility Clinics LLC

OTHER