NCT03778736已完成不适用
Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 586
- 试验地点
- 5
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ICSI indicated partcipants
排除标准
- •severe medical disease
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 16 weeks
Continued pregnancy after 12 weeks of gestation
次要结局
- Embryo developmental rate(6 days of culture)
- Biochemical pregnancy(Two weeks)
- Clinical pregnancy rate(7 weeks)
研究者
Muhammad Fawzy
IVF Lab Director
Ibn Sina Hospital
研究点 (5)
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