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

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

Official Title
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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

Conditions
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Controlled Ovarian Stimulation

Intervention / Treatment
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* Drug: Ganirelix acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ganilever (ganirelix acetate)<br>Prefilled syringe / 0.25mg/0.5mL | Drug: Ganirelix acetate<br> <br> |
| Active Comparator: Orgalutran (ganirelix acetate)<br>Prefilled syringe / 0.25mg/0.5mL | Drug: Ganirelix acetate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |