Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
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.
Inclusion Criteria:

 -  Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised
 2003 Rotterdam Consensus

 -  Female subjects suitable for IVF/ICSI, undergoing first or second attempt

 -  18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least
 from Visit 0 (V0)

 -  Normal FSH value (less than 10 international unit per liter [IU/L]) on Day 3 of
 spontaneous cycle within 12 months prior to the trial

 -  Anti Mullerian Hormone (AMH) value (greater than 1.5 nanogram per milliliter [ng/mL])
 of a spontaneous cycle within 12 months prior to the trial or at least at V0

 -  No history of active genito-urinary infection

 -  Normal thyroid function (or adequate substitution for at least 3 months)

 -  Negative cervical papanicolaou test within the last 12 months prior to study entry

 -  No gonadotropins, for at least one month prior to the trial

 -  No metformin therapy for at least one month prior to Visit 1 (V1)

 -  Subject who is able to participate in the trial and has provided written, informed
 consent.

 Exclusion Criteria:

 -  Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any
 contraindication to pregnancy or carrying pregnancy to term

 -  Drilling 3 months prior to V0

 -  Uterine malformation, diethylstilbestrol syndrome, synechia

 -  Female subjects with World Health Organization (WHO) Type I or III anovulation

 -  Female subjects with hyperprolactinemia

 -  Female subjects with more than 2 recurrent miscarriages (early or late, and for any
 reasons)

 -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for
 subject or partner

 -  Abnormal gynecological bleeding of undetermined origin

 -  History of major thromboembolic disease

 -  Endometriosis (Grade III or IV)

 -  Presence or history of malignant tumors and related treatment

 -  Known case of tumors of the hypothalamus or pituitary gland

 -  Clinically significant systemic disease or clinically significant abnormal hematology,
 chemistry, or urinalysis results at screening

 -  Known allergic reaction or hypersensitivity to Cetrotide® or Ovitrelle®

 -  Any active substance abuse or history of drug, medication or alcohol abuse in the past
 5 years

 -  Participation in another clinical trial within 3 months prior to study entry.