Analysis of Two Therapeutic With CetrotideĀ® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Brief Summary
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of CetrotideĀ® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).
Detailed Description
Polycystic ovarian syndrome population is an androgenic syndrome characterized by a wide spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes and presence of specific ultrasonic features. CetrotideĀ®, cetrorelix acetate, is an antagonist of luteinizing-hormone-releasing hormone (LHRH). CetrotideĀ® is registered in 70 countries (including France) for the prevention of premature ovulation in subjects undergoing a controlled ovarian stimulation, followed by oocyte pick-up and ARTs. OvitrelleĀ®, active ingredient human chorionic-gonadotropin alfa, is administered to trigger final follicular maturation and luteinization after stimulation of follicular growth. OBJECTIVES Primary objective: * To compare the hormonal level of plasmatic estradiol on the releasing day (day of r-hCG administration) induced by CetrotideĀ® 0.25 mg/day started on Day 1 (Group A: Day 1) or on Day 7 (Group B: Day 7) of the menstrual cycle (Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI procedures. Secondary objectives: * To compare the hormonal changes during the stimulation induced by CetrotideĀ® in A and B Groups * To assess by ultrasound scans (US) the follicular development induced by CetrotideĀ® in A and B Groups * To assess biological and clinical outcomes induced by CetrotideĀ® in A and B Groups * To monitor safety of Cetrotide in A and B Groups The trial will be conducted on an outpatient basis. Once each subject has met all eligibility criteria, they will be randomly assigned in one of the two treatment groups.
Interventions
Primary Outcomes
Trial Information
NCT01185704
Completed
INTERVENTIONAL
PHASE3
Merck KGaA, Darmstadt, Germany
December 15, 2025