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

LG Life Sciences

Status and phase

Completed

Phase 4

Conditions

Controlled Ovarian Stimulation

Treatments

Drug: Ganirelix acetate

Study type

Interventional

Funder types

Industry

Identifiers

LG-GNCL001

Details and patient eligibility

About

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

Enrollment

255 patients

Sex

Female

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

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