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
Intervention: Cetrorelix acetate; Cetrorelix acetate; Recombinant Human Choriogonadotropin (r-hCG); Recombinant human follicle stimulating hormone (r-hFSH)
Intervention description: 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
Intervention MeSH terms: Cetrorelix; Chorionic Gonadotropin; Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Cetrorelix acetate; follitropin alfa; human chorionic-gonadotropin alfa; follicular maturation; pregnancy; ovarian stimulation

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).
    

Eligibility criteria:

        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.