Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 3

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
      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).
    

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.

      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.
    

Intervention name(s): Cetrorelix acetate; Cetrorelix acetate; Recombinant Human Choriogonadotropin (r-hCG); Recombinant human follicle stimulating hormone (r-hFSH)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) until r-hCG day (at least 2 follicles >=17 mm); Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) until r-hCG day (at least 2 follicles >=19 mm); The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day; Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period [S1]) until r-hCG day
Other intervention name(s): Cetrotide®; Cetrotide®; Ovitrelle®
Intervention MeSH terms: Cetrorelix; Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation