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

Infertility, Female Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458768
• Other study ID #: LG-IMHCL001
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2015
• Last updated: January 4, 2016
• Start date: July 2013

Study information

• Verified date: May 2015
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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:

? Advanced maternal age (>=40 years) or any other risk factor for Poor Ovarian Response (POR)

? A previous POR (<=3 oocyte with a conventional stimulation protocol)

? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• IVF-M HP Inj.

• Menopur® Inj.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Retrieved Oocytes		36 hrs (±3 hrs) after administration of the ovulation stimulant	No