Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Intervention: IVF-M HP Inj.; Menopur® Inj.
Intervention MeSH terms: Menotropins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Female
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: No

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