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临床试验/NCT04818593
NCT04818593已完成不适用

A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年6月18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
108
试验地点
1
主要终点
Percentage of Good Quality Blastocyst Formation

研究概览

简要总结

The primary objective of this study is to evaluate whether the percentage of good quality embryo formation following Intracytoplasmic Sperm Injection (ICSI) is improved with the use of ZyMot method of microfluidic sperm separation compared to density gradient.

详细描述

During an in vitro fertilization (IVF) cycle, eggs are removed from a woman's ovaries via a minor surgical procedure and are inseminated with sperm in order to create embryos. The insemination process can be via standard IVF or intracytoplasmic sperm injection (ICSI.) Standard IVF is the process of placing thousands of sperm in a culture dish with one or more eggs and allowing them to interact on their own. ICSI is the process by which one sperm is directly injected into each egg.

Prior to using the sperm for insemination, a semen sample is processed and washed in order to obtain the healthiest sperm. A standard sperm preparation procedure is density gradient, in which the sperm is spun via centrifugation and separated from the seminal fluid. An alternate method is via microfluidics, by which the sperm swim up a microfluidic gradient created by a microporous filter between two chambers of a device. Sperm that are capable of navigating through this filter and reaching the end chamber are presumed to be the healthiest sperm. There is some data revealing that ZyMot microfluidics yields healthier sperm compared to the density gradient technique.

The aim of the study is to evaluate whether good quality embryo formation is any different following insemination with sperm separated by microfluidics compared to density gradient.

On the day of oocyte retrieval, the sperm sample will be split between the two different processing methods: density gradient and ZyMot microfluidics. In the event that there are 6 or more mature oocytes and ICSI will be used for insemination, half of the oocytes will be inseminated with sperm processed by density gradient and half with sperm processed by ZyMot microfluidics. The percentage of good quality embryo formation will be compared between the two groups.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of Good Quality Blastocyst Formation

时间窗: Culture Day 5 or 6

Good quality embryos will be defined as blastocyst stage embryos on day 5 or 6 of culture with an overall quality grade of good or fair. Embryo morphology assessment includes two parts: an Overall Grade and the Stage. Grading is a subjective assessment of the overall quality of the embryo as good, fair, or poor, and is based on assessment of certain characteristics of the embryo, such as fragmentation, symmetry, inner cell mass (ICM) quality and trophectoderm quality. The percentage will be reported for both arms (ZyMot compared to density gradient).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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