NCT03051087已完成4 期
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
LG Life Sciences2 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ganilever (ganirelix acetate)
Experimental
Prefilled syringe / 0.25mg/0.5mL
干预措施: Ganirelix acetate (Drug)
Orgalutran (ganirelix acetate)
Active Comparator
Prefilled syringe / 0.25mg/0.5mL
干预措施: Ganirelix acetate (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: about 10 days after randomization
次要结局
- 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))
- 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)
- 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)
研究者
研究点 (2)
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