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
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
研究组 & 干预措施
oocytes treated with calcium ionophore
Oocytes treated with a ready-to-use ionophore compound (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF). After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes subjected to AOA will transfer to the same time-lapse culture dish with the controlled sibling group.
干预措施: calcium ionophore (Other)
oocytes undergo routine IVF/ICSI protocol
Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine.
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)