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

NCT02458768 | Completed Phase 4 Results

• 1 other identifier: LG-IMHCL001
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Number of Retrieved Oocytes

  36 hrs (±3 hrs) after administration of the ovulation stimulant

Study Arms (2)

IVF-M HP Inj.

EXPERIMENTAL

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.

Menopur® Inj.

ACTIVE COMPARATOR

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.

Interventions

IVF-M HP Inj. DRUG

IVF-M HP Inj.

Menopur® Inj. DRUG

Menopur® Inj.

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Results Point of Contact

• Title: Jonghee Jin
• Organization: LG Life Sciences

jonghee@lgls.com

82-2-6924-3122

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2015-05