Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.

A Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of s.c. Administration of IVF-M HP Inj. Versus Menopur® Inj. in Infertility Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies (ART) Such as in Vitro Fertilization-embryo Transfer (IVF-ET)

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.

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