efficacy and safety of fe 999049 in controlled ovarian stimulation in japanese women

Conditions: Infertility

Summary: to demonstrate non-inferiority of fe 999049 compared to follistim with respect to number of oocytes retrieved in japanese ivf/icsi patients undergoing controlled ovarian stimulation.


Eligibility criteria:
inclusion criteria: * informed consent documents signed prior to any trial-related procedures. * in good physical and mental health. * japanese females between the ages of 20 and 40 years. * infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage i/ii (defined by the revised american society for reproductive medicine (asrm) classification) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (ivf) and/or intracytoplasmic sperm injection (icsi) treatment using ejaculated sperm from male partner. * infertility for at least 1 year before randomization (not applicable in case of tubal or severe male factor infertility). * the trial cycle will be the participant's first controlled ovarian stimulation cycle for ivf/icsi. * hysterosalpingography, hysteroscopy, saline infusion sonography or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to screening. this also includes women who have been diagnosed with any of the above medical conditions but have had them surgically corrected within 1 year prior to screening. * transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and fallopian tubes and surrounding tissue without evidence of significant abnormality (e.g. no hydrosalpinx) within 1 year prior to screening. both ovaries must be accessible for oocyte retrieval. * early follicular phase (cycle day 2-4) serum levels of follicle stimulating hormone (fsh) between 1 and 15 iu/l (results obtained within 3 months prior to screening). * body mass index (bmi) between 17.5 and 32.0 kg/m\^2 (both inclusive) at screening. exclusion criteria: * known endometriosis stage iii-iv (defined by the revised asrm classification). * one or more follicles \>10 mm (including cysts) observed on the transvaginal ultrasound prior to start of stimulation on stimulation day 1 (puncture of cysts prior randomization is allowed). * known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy). * known abnormal karyotype of participant or of her partner. in case the sperm production is severely impaired (concentration \<1 million/ml), normal karyotype, including no y chromosome microdeletion, must be documented. * active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. * any known clinically significant systemic disease (e.g. insulin-dependent diabetes). * any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease. * known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.