To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®

A Multicenter, Randomized, Treated-controlled, Parallel, Open Label Study to Compare and Evaluate the Efficacy and Safety of Ganilever PFS and Orgalutran® in Infertility Women for Assisted Reproductive Technologies

to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies

Study Overview

• Status: Completed
• Conditions: Controlled Ovarian Stimulation
• Intervention / Treatment: Drug: Ganirelix acetate

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • CHA Bundang Medical Center, CHA University
  • Seoul, Korea, Republic of
    • CHA Gangnam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• An adult female between the ages of 20 and 39 at the time of screening
• Patients whose mean menstrual cycle was between 25 and 35 days
• Patients whose FSH (follicle stimulating hormone) concentration does not exceed 13 mIU / mL at screening
• Patients diagnosed with infertility due to one or more of the following A. Trouble Factors B. Male Factors C. Unexplained D. Uterine factors
• Patients with previous IVF experience less than 3
• Patient who signed the written consent after hearing the explanation of the purpose, method and effect of the clinical trial

Exclusion Criteria:

• If the sperm donor (spouse or non-spouse) is a severe male factor (Non obstructive azoospermia)
• Patients who were diagnosed as PCOS (polycystic ovary syndrome) during screening
• Patient with abnormal uterine bleeding during screening
• Patients diagnosed with primary ovarian failure
• Patients who has ovarian cysts that are not related to PCOS during screening
• Patients with tubal hydrops
• Patients with untreated non-reproductive endocrine disease
• Patients with a deformity of the reproductive organs that can not be conceived, or fibroids of the uterus that can not be conceived (only for submucosal myoma)
• Patients with less than 2 ovaries (0 or1)
• Patients with ovarian, breast, uterus, hypothalamus, or pituitary malignancies
• Patients with BMI <18 or BMI> 30
• Patients with an LH concentration of less than 1.2mIU / mL during screening
• Poor ovarian responder by bologna criteria
• Patients with moderate or severe renal impairment (creatinine clearance <60 mL / min) or liver function impairment (ALT or AST,> 5 times normal)
• Patients who experienced Grade 4 or higher OHSS (ovarian hyperstimulation syndrome) before
• Patients who are contraindicated for pregnancy
• Patients being pregnant or lactating
• Patients with hypersensitivity to IP
• Patients who have participated in other medication-related clinical trials since enrollment in this study, or have participated in other clinical trials within 3 months (90 days) before enrolling in this trial

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: Ganilever (ganirelix acetate); Prefilled syringe / 0.25mg/0.5mL	Drug: Ganirelix acetate
Active Comparator: Orgalutran (ganirelix acetate); Prefilled syringe / 0.25mg/0.5mL	Drug: Ganirelix acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of oocytes retrieved	about 10 days after randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with LH (luteinizing hormone) rise > 10 mIU/mL	about 8~9 days after randomization (visit 4)
Oocyte quality	Day of oocyte retrieval (about 10 days after randomization)
Total administration dosage (IU) of Follitrope® PFS	During 8~9 days after randomization (until administration hCG)
Total administration duration (day) of Follitrope® PFS	During 8~9 days after randomization (until administration hCG)
Total administration dosage (mL) of Ganilever PFS or Orgalutran®	From 4~5 days after randomization to 8~9 days after randomization
Total administration duration (day) of Ganilever PFS or Orgalutran®	From 4~5 days after randomization to 8~9 days after randomization
Fertilization rate (%)	Day of oocyte retrieval (about 10 days after randomization)
Implantation rate (%)	About 4~5 weeks after Embryo transfer
Chemical pregnancy (%)	About 2 weeks after oocyte retrieval
Clinical pregnancy (%)	About 4~5 weeks after Embryo transfer
Ongoing pregnancy (%)	About 10~11 weeks after oocyte retrieval

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Ganirelix
• Other Study ID Numbers: LG-GNCL001