Clinical trial NCT00702845 (phase 3, status: completed)
Conditions: infertility
ICD codes: N46.8, N46.9, N97.9, N97.0, N97.1, N97.2, N97.8
Drugs: corifollitropin alfa (org 36286), recfsh (follitropin beta), gonadatropin releasing hormone (gnrh) antagonist (ganirelix), human chorion gonadatropin (hcg), placebo-recfsh (follitropin alfa), placebo-corifollitropin alfa
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
Eligibility criteria:

        Inclusion Criteria:

          -  Females of couples with an indication for COS and IVF or ICSI;

          -  >=18 and <= 36 years of age at the time of signing informed consent;

          -  Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;

          -  Normal menstrual cycle length: 24-35 days;

          -  Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is
             allowed);

          -  Willing and able to sign informed consent.

        Exclusion Criteria:

          -  History of/or any current (treated) endocrine abnormality;

          -  History of ovarian hyper-response or ovarian hyperstimulation syndrome

        (OHSS);

          -  History of/or current polycystic ovary syndrome (PCOS);

          -  More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS
             in the early follicular phase (menstrual cycle day 2-5);

          -  Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm;
             visible on USS);

          -  Presence of unilateral or bilateral hydrosalphinx (visible on USS);

          -  Presence of any clinically relevant pathology affecting the uterine cavity or fibroids
             >= 5 cm;

          -  More than three unsuccessful IVF cycles since the last established ongoing

        pregnancy (if applicable);

          -  History of non- or low ovarian response to FSH/hMG treatment;

          -  History of recurrent miscarriage (3 or more, even when unexplained);

          -  FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during
             the early follicular phase: menstrual cycle day 2-5);

          -  Any clinically relevant abnormal laboratory value based on a sample taken during the
             screening phase;

          -  Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
             undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);

          -  Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,

        gastro-intestinal, hepatic, renal or pulmonary disease;

          -  Abnormal karyotyping of the patient or her partner (if karyotyping is performed);

          -  Smoking more than 5 cigarettes per day;

          -  History or presence of alcohol or drug abuse within 12 months prior to signing
             informed consent;

          -  Previous use of Org 36286;

          -  Use of hormonal preparations within 1 month prior to randomization;

          -  Hypersensitivity to any of the concomitant medication prescribed as part of the
             treatment regimen in this protocol;

          -  Administration of investigational drugs within three months prior to signing informed
             consent.