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临床试验/NCT03778736
NCT03778736已完成不适用

Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes

Ibn Sina Hospital5 个研究点 分布在 1 个国家目标入组 586 人开始时间: 2018年1月27日最近更新:
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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Fawzy

IVF Lab Director

Ibn Sina Hospital

研究点 (5)

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