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临床试验/NCT03522350
NCT03522350终止不适用

Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
18
试验地点
1
主要终点
Number of Day 3 Embryos

研究概览

简要总结

The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.

详细描述

This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.

Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.

"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.

Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •40 years of age or younger (maternal)
  • •65 years of age or younger (paternal)
  • •Fresh or frozen (including donor) sperm can be used
  • •Fresh oocytes only (including donor)
  • •Frozen embryos from this study can be included in the outcome portion of this study.
  • •Single or double Blastocyst transfer only

排除标准

  • •3 or more previous failed cycles
  • •Sperm obtained by testicular biopsy
  • •Co-culture patients

研究组 & 干预措施

EmbryoScope

Active Comparator

Standard of care embryo incubator.

干预措施: EmbryoScope (Device)

EmbryoScope+

Experimental

New experimental embryo incubator.

干预措施: EmbryoScope+ (Device)

结局指标

主要结局

Number of Day 3 Embryos

时间窗: Day 3 post retrieval

Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+

Number of Day 5 Embryos

时间窗: Day 5 post retrieval

Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+

次要结局

  • Pregnancy Rate(2 weeks post retrieval)
  • Implantation Rate(5-6 weeks post retrieval)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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