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临床试验/NCT04061486
NCT04061486已完成不适用

Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

IVI Sevilla1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年8月8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
84
试验地点
1
主要终点
Pregnancy rate

研究概览

简要总结

The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:

  • Does microfluidic sorting improve pregnancy rate compared to MACS?
  • Does microfluidic sorting improve fertilization rate compared to MACS?
  • Does microfluidic sorting improve implantation rate compared to MACS?
  • Does microfluidic sorting improve blastocyst development rate compared to MACS?

Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.

Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.

详细描述

In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.

Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • Oocyte recipient patients

排除标准

  • Sperm concentration < 5 Mill/ml
  • Percentage of motile sperm < 15%

结局指标

主要结局

Pregnancy rate

时间窗: Mar 2019 - Oct 2021

Total of positive pregnancies / total of patients with embryo transfer

次要结局

  • Implantation rate(Mar 2019 - Oct 2021)
  • Blastocyst rate(Mar 2019 - Oct 2021)
  • Fertilization rate(Mar 2019 - Oct 2021)

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

研究点 (1)

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