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临床试验/NCT05866484
NCT05866484已完成不适用

Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better

Clinique Ovo1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2023年5月10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
280
试验地点
1
主要终点
Clinical Pregnancy Rate

研究概览

简要总结

Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate.

The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men with high DNA fragmentation (>20%) undergoing TESA-ICSI or Zymot-ICSI

排除标准

  • Spouse with advanced maternal age (> 40 years)
  • Egg donation cycle

结局指标

主要结局

Clinical Pregnancy Rate

时间窗: approximately 8 weeks

Compare clinical pregnancy rate in couples with high Sperm DNA fragmentation

次要结局

  • Number of utilizable blastocysts obtained(Approximately 20 days)

研究者

发起方
Clinique Ovo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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