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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: IVF-M HP Inj.; Drug: Menopur® Inj.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: IVF-M HP Inj.
Active Comparator: 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).	Drug: Menopur® Inj.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Menotropins
• Other Study ID Numbers: LG-IMHCL001