Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)

Inclusion Criteria: * Japanese females of infertile married couples with an indication for COH and IVF with or without ICSI. * At least 20 but not older than 39 years of age at the time of screening. * A body mass index (BMI) between 18 and 29. * Normal menstrual cycle with a range of 24-35 days and an intra-individual variation of plus or minus 3 days (but never outside the 24-35 days range). * Infertile couple that is willing to give written informed consent. * Determination of inclusion criteria * is determined in view of the planned therapeutic indication. * is determined based on ethical considerations for the subjects (not younger than 20) and also in view of the planned therapeutic indication (not older than 39) * is determined to avoid bias on the effects of Org 37462 by emaciation and obesity. * is determined to avoid the influences of endogenous hormones considering the purpose of this trial to select the minimal effective dose of Org 37462. * is determined from the ethical consideration of the subjects. Exclusion Criteria: * History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS) or polycystic ovaries according to USS, (treated) hyperprolactinemia or evidence of ovarian dysfunction. * History of non- or low- ovarian response to FSH/hMG treatment. * Abnormal cervical smear according to the Papanicolaou (\>= class III) or Bethesda (\>= CIN 1) scale. * History of/or current Type I hypersensitivity (urticaria, eczema, hay fever, asthma), meaning that the subject is using prescribed medication on a regular basis or that the subjects history is prohibitive for Org 37462 treatment according to the clinical opinion of the sub-investigator. * Any hormone value outside the reference range during the early follicular phase as measured by the central laboratory (Japan) \[FSH, LH, E2, P, androstenedione (AD), dehydroepiandrosterone sulphate (DHEAS), testosterone (T), thyroid stimulating hormone (TSH) and prolactin\]. * Any clinically significant abnormal laboratory value of the central laboratory (Japan) (routine hematology, blood biochemistry). * Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of both ovaries, thus excluding subjects with only one ovary. * Contra-indications for the use of gonadotropins i.e., * tumors of ovary, breast, uterus, pituitary or hypothalamus. * pregnancy or lactation. * undiagnosed vaginal bleeding. * hypersensitivity to any of the substances in recFSH (FSH, sucrose, sodium citrate, polysorbate 20 and sodium chloride, L-methionine). * ovarian cysts or enlarged ovaries not related to PCOS. * malformation of the sexual organs incompatible with pregnancy. * fibroid tumors of the uterus incompatible with pregnancy. * Use of hormonal preparations within 1 month prior to screening. * Hypertension (systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>90 mm Hg) or treated hypertension. * Epilepsia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease. * Administration of investigational drugs within 3 months prior to screening.