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

Phase 4

Completed

Conditions: Infertility, Female

Interventions: Drug: IVF-M HP Inj.
Drug: Menopur® Inj.

Registration Number: NCT02458768

Lead Sponsor: LG Life Sciences

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 112

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVF-M HP Inj.	IVF-M HP Inj.	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).
Menopur® Inj.	Menopur® Inj.	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).

Primary Outcome Measures