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临床试验/NCT02974517
NCT02974517Unknown不适用

The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?

The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Among all the strategies that the embryologists have tried, much work has been done to find better embryo culture conditions and embryo quality evaluation system. Currently, most centers in the world, including ours, are still using conventional incubators and manual embryo scoring system. This traditional method has several limitations, such as unstable environment during culture, and embryo scores can be different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely daily use. In addition, its KID Score system can help embryologist select high quality embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our center.

详细描述

All patients included into this study are divided into three groups:

  1. Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.
  2. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
  3. Conventional Group: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.

The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate, cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.

研究设计

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

入排标准

年龄范围
22 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First IVF/ICSI cycle;
  • With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);
  • Age under 38 years old;
  • With normal uterine;
  • Tubal factor infertility

排除标准

  • Pre-implantation genetic diagnosis cycles;
  • Oocyte donation or sperm donation cycles.

结局指标

主要结局

Clinical pregnancy rate

时间窗: 5 weeks after embryo transfer

5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

次要结局

  • 2 pronucleus (2PN) fertilization rate(48 hours after oocyte retrieved day)
  • Blastocyst formation rate(6 days after oocyte retrieved day)
  • High quality embryo rate(72 hours after oocyte retrieved day)

研究者

发起方
The First Affiliated Hospital of Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yingpu Sun

Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University

The First Affiliated Hospital of Zhengzhou University

研究点 (1)

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