A Phase IIIb Randomized Open-label Study to Compare Between IVF/ICSI Outcomes Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART.
Polycystic ovarian syndrome population is an androgenic syndrome characterised by a wide
spectrum of clinical manifestations such as obesity, hirsutism, insulin resistance, diabetes
and presence of specific ultrasonic features.
Cetrotide, cetrorelix acetate, is an antagonist of luteinising-hormone-releasing hormone
(LHRH). Cetrotide 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. Ovid[t]rel[le]®, active ingredient human chorionic-gonadotropin
alfa, is administered to trigger final follicular maturation and luteinisation after
stimulation of follicular growth.
- To compare the hormonal level changes of plasmatic oestradiol on the releasing day
[day of Rh-family, C glycoprotein (r-hCG) administration] induced by Cetrotide 0.25
mg/day started on Day 1 (Goup A: D1) or on Day 7 (Goup B: D7) of the menstrual cycle
(Day 0 (S0) or Day 6 (S6) of stimulation) in PCO subjects undergoing IVF/ICSI
- To compare the hormonal changes during the stimulation induced by Cetrotide in A and B
- To assess by ultrasound scans (US) the follicular development induced by Cetrotide in A
and B Groups
- To assess biological and clinical outcomes induced by Cetrotide 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Estradiol (E2) level comparison on the releasing day (day of r-hCG administration) in A and B Groups.
Inclusion Visit (Visit 0) and everyday from Day 7 to day of r-hCG administration (ie. at least 2 follicles≥ 17mm in group Day 1 and at least 2 follicles ≥ 19 mm in group Day 7)
Dr Etienne VARLAN
Merck Lipha Santé
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)