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

Controlled Ovarian Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051087
• Other study ID #: LG-GNCL001
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2019
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Controlled Ovarian Stimulation

Intervention

Drug:
• Ganirelix acetate

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Gyeonggi-do
Korea, Republic of	CHA Gangnam Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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