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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Ganirelix

Criteria

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