Clinical trial NCT01185704 (phase 3, status: completed)
Conditions: polycystic ovarian syndrome
ICD codes: E28.2
Drugs: cetrorelix acetate, cetrorelix acetate, recombinant human choriogonadotropin (r-hcg), recombinant human follicle stimulating hormone (r-hfsh)
SMILES: CC(C)C[C@H](NC(=O)[C@@H](CCCNC(N)=O)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC1=CN=CC=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC2=CC=CC=C2C=C1)NC(C)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O, CC(C)C[C@H](NC(=O)[C@@H](CCCNC(N)=O)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC1=CN=CC=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC2=CC=CC=C2C=C1)NC(C)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
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.