NCT05722067已完成不适用
Improved the Low Fertilization Rates and Increased the High-quality Embryogenesis by Treatment With Calcium Ionophore GM508 CultActive Optimized Medium in Vitro Fertilization (IVF) Patients
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- fertilization rate
研究概览
简要总结
GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Low fertilization rate in previous IVF cycle (<30%), or
- •Poor embryo developmental problems in previous IVF cycle, or
- •Diminished ovarian reserve (AMH<1.2 or AFC<5) and/or more than 40 y/o.
排除标准
- •Without or just one oocyte picked up
结局指标
主要结局
fertilization rate
时间窗: Day 1
The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes
次要结局
- pregnancy outcome(1 year)
- blastocyst formation rate(Day 5)
- top-quality blastocyst formation rate(Day 5)
研究者
研究点 (1)
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