Polycystic Ovarian Syndrome Clinical Trial
Official title:
A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in 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 (IVF/ICSI).
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (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).
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.
Cetrotide®, cetrorelix acetate, is an antagonist of luteinizing-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. Ovitrelle®, 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 Cetrotide® 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 Cetrotide® in A and B
Groups
- 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
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