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临床试验/NCT05494216
NCT05494216已完成不适用

Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Ganin Fertility Center2 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2022年8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
515
试验地点
2
主要终点
Aneuploidy rate

研究概览

简要总结

Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts

详细描述

Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection.

PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Case must have PGT-A for all of her blastocysts
  • Males diagnosed with abnormal sperm DNA fragmentation index (> 20%).
  • Normo responder (> 5 mature oocytes)
  • Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI

排除标准

  • Leukocytospermia
  • Presence of varicocele.
  • Known genetic abnormality
  • Use of sperm or oocyte donors
  • Use of gestational carrier
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

结局指标

主要结局

Aneuploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of aneuploid blastocysts

Euploidy rate

时间窗: 15 days post ICSI

Defined as the proportion of euploid blastocysts

Low mosaic rate

时间窗: 15 days post ICSI

Defined as the proportion of low mosaic blastocysts

High mosaic rate

时间窗: 15 days post ICSI

Defined as the proportion of high mosaic blastocysts

次要结局

  • Cleavage rate(3 days)
  • Fertilization rate(1 day)
  • Blastocyst development rate(5-6 days)
  • Blastocyst quality rate(5-6 days)

研究者

发起方
Ganin Fertility Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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