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临床试验/NCT04144621
NCT04144621已完成不适用

The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential

Ganin Fertility Center1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2018年1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
189
试验地点
1
主要终点
Blastocyst morphological grading

研究概览

简要总结

Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).

详细描述

Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate?

Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG).

Statistical analysis done using SPSS version 22.

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
— 至 37 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All cases in this study have to reach the blastocyst stage.
  • Female age ≤37 years old.
  • Male sperm count ≥ 5 million.

排除标准

  • Usage of sperm selection techniques.
  • Testicular aspiration or testicular biopsies.
  • Oocyte or sperm donation.

结局指标

主要结局

Blastocyst morphological grading

时间窗: 5-6 days after ICSI

Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).

Implantation rate

时间窗: 6 weeks of pregnancy

Percentage of the implanted embryos number for each group / number of transferred embryos.

次要结局

  • Blastulation rate(5-6 days of ICSI)
  • Pregnancy rate(After 2 weeks of embryo transfer)
  • Fertilization rate(16-19 hours of ICSI)

研究者

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

研究点 (1)

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