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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: IVF-M HP Inj.
* Drug: Menopur® Inj.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVF-M HP Inj.<br>administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). | Drug: IVF-M HP Inj.<br> <br> |
| Active Comparator: Menopur® Inj.<br>administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). | Drug: Menopur® Inj.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Retrieved Oocytes |  | 36 hrs (±3 hrs) after administration of the ovulation stimulant |