Open-label, Parallel-group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 μg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-ovulation Secondary to Hypothalamic-pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa
- Premenopausal women aged between 20 to 39 years inclusive and wishing to conceive.
- BMI of 17.0 to 29.0 kg/m2 inclusive (value up to first decimal place).
- No clinically significant abnormalities in serum TSH, DHEA-S, 17-OHP, PRL and FSH
levels in the early follicular phase.
- Anovulation or oligo-ovulation.
- Any one of the following: spontaneous menstruation (at least twice per year) or a
positive response to progestin as evidenced by menstruation.
- Eligible for ovarian stimulation with gonadotropins (e.g. documented failure to
ovulate or achieve pregnancy with anti-estrogenic therapy such as clomiphene
- Male partner with normal semen analysis, as defined by WHO standards, within 12
months prior to date of informed consent.
- Normal cervical smear results (PAP score ≤ II) taken within 12 months prior to date
of informed consent; if not available a cervical smear will be performed as part of
- Full comprehension of the trial and voluntary consent obtained in writing prior to
participation in this trial.
- Infertility involving gynecological factors other than anovulation or oligo-ovulation
secondary to hypothalamic-pituitary dysfunction (Grade 1 Amenorrhea, Oligomenorrhea
or Anovulatory Cycles) or PCOS, and for whom OI therapy is contraindicated.
- Subjects with known surgical/histological diagnosis of endometriosis greater than
Stage II (American Fertility Society classification), or endometriosis requiring
- Infertility secondary to amenorrhea of uterine cause.
- Infertility secondary to primary or premature ovarian failure.
- Infertility secondary to known adrenal or thyroid dysfunction, or hyperprolactinemia.
- Failure of ovulation in 2 or more consecutive previous cycles with any gonadotropins.
- Subjects in whom pregnancy is contraindicated, e.g. malformations of sexual organs or
fibroid tumors of the uterus incompatible with pregnancy.
- Extrauterine pregnancy in the previous 3 months.
- History or presence of intracranial tumor (e.g. hypothalamic or pituitary tumor).
- Presence of or suspected gonadotropin- or estrogen-dependent malignancy (e.g.
ovarian, uterine or mammary carcinoma).
- Untreated endometrial hyperplasia.
- Abnormal hemorrhage of the reproductive tract of unknown origin.
- History of severe ovarian hyperstimulation syndrome (OHSS) (Classification of OHSS
Severity, Japan Reproductive/Endocrine Working Group).
- Clinically significant systemic disease (e.g. insulin-dependent diabetes, epilepsy,
severe migraine, intermittent porphyria, hepatic, renal or cardiovascular disease,
severe corticosteroid-dependent asthma).
- Participation in another clinical trial within 3 months prior to date of informed
consent or simultaneous participation in another clinical trial.
- Gonadotropin treatment within 2 months prior to date of informed consent.
- Legal incapacity or limited legal capacity.