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临床试验/NCT01635049
NCT01635049已完成不适用

Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth

Progyny, Inc.2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Progyny, Inc.
入组人数
110
试验地点
2
主要终点
Eeva time-lapse parameters and CCS

研究概览

简要总结

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

详细描述

The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

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
— 至 43 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Subject is ≤43 years of age.
  • Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
  • Willing to have all 2PN embryos monitored by Eeva
  • Not previously enrolled in this study.
  • No concurrent participation in another clinical study.
  • Willing to comply with study protocol and procedures and able to speak English.
  • Willing to provide written informed consent.

排除标准

  • Prior IVF cycle with < 4 x 2PN
  • Diminished ovarian reserve as demonstrated by any one of the following:
  • BAFC < 6 at time of cycle start
  • Maximum prior FSH > 15
  • AMH < 0.5

结局指标

主要结局

Eeva time-lapse parameters and CCS

时间窗: 5-6 days

Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.

次要结局

  • Correlation of time-lapse parameters collected by the Eeva System and implantation rate.(6 weeks)
  • Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate(6 weeks)
  • Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate(7 - 8 weeks)
  • Correlation of time-lapse parameters collected by the Eeva System and delivery rate(live birth)
  • Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate(live birth)
  • Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate(live birth)

研究者

发起方
Progyny, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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