Overview

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