multicenter, randomized, open label, parallel study to evaluate the efficacy & safety of ivf-m hp inj. vs. menopur® inj.

Conditions: Infertility, Female

Summary: the objective of this study was to demonstrate the non-inferiority of ivfm hp inj. by evaluating its efficacy versus menopur® inj. in infertility women undergoing the in vitro fertilization and embryo transfer (ivf-et) among the assisted reproductive technologies.


Eligibility criteria:
inclusion criteria: * adult women from 20 through 39 years of age at the screening * subjects with the mean menstrual cycle day (mcd) of 25 to 35 days * subjects with the follicle stimulating hormone (fsh) concentration at the screening not exceeding the upper limit of the normal range (uln) * those diagnosed with infertility due to at least one of the following causes of infertility * fallopian tubal factor * infertility due to unknown cause * male infertility * complex factor * subjects with the normal ovarian and uterine function * subjects with not more than 3 times of the prior experience of in vitro fertilization * subjects who had neither administered clomiphene citrate within 30 days nor gonadotropin within 14 days of the ip administration day * subjects who were informed on the objective, method and effect etc. of the clinical study and signed the informed consent form exclusion criteria: * subjects contraindicated to pregnancy * subjects with bmi \> 30 (bmi; kg/m2) * subjects diagnosed with polycystic ovary syndrome (pcos) * subjects who had experienced previously at least grade 4 ovarian hyperstimulation syndrome (ohss) * subjects with poor response to gonadotropin (according to the bologna criteria\* below) \*at least two of the following three features must be present: ① advanced maternal age (\>=40 years) or any other risk factor for poor ovarian response (por) ② a previous por (\<=3 oocyte with a conventional stimulation protocol) ③ an abnormal ovarian reserve test (i.e. antral follicle count (afc) \< 5 follicles or anti-mullerian hormone (amh) \< 0.5 ng/ml) * those with abnormal metrorrhagia due to unknown cause at the screening * subjects with submucosal uterine leiomyoma * subjects with at least borderline ovarian tumor * subjects with a history or malignant tumor in breast * subjects with hydrosalpinx not removed by operation * subjects with the thyroid stimulating hormone (tsh) level out of the normal range at the screening * subjects with a history of malignant tumor within 5 years prior to the screening * subjects with severe disease potentially affecting the study such as pituitary insufficiency upon the investigator's judgment (e.g., heart failure, renal failure, hepatic failure or adrenal insufficiency etc.) * subject with hiv- or syphilis-positive result at the screening * subjects with a psychiatric disorder at the screening or those who failed in understanding the objective and method of this clinical study * subject diagnosed with alcohol or drug abuse within 3 months prior to the screening * subjects with a history of hypersensitivity to the investigational products of this clinical study * subjects with a current or history of thromboembolism in vein or artery * subjects with a history of genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption etc. * subjects who had participated in another clinical study related to a drug administration after the enrollment in this study or who had participated in another clinical study within 3 months prior to the enrollment in this study * others including the subjects for whom it was considered difficult to conduct this clinical study upon the principal investigator's judgment