| Eligibility |
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.
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