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.