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临床试验/NCT03687697
NCT03687697撤回4 期

A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Embryo development

研究概览

简要总结

This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.

详细描述

Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system.

Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage.

G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6.

C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care.

C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • 40 years of age or younger (maternal)
  • 65 years of age or younger (paternal)
  • 10 or more oocytes
  • Fresh or frozen oocytes (including donor)
  • Fresh or frozen (including donor) sperm can be used
  • ICSI only
  • Frozen embryos from this study can be included in the outcome portion of this study.
  • PGD and/or PGS patients included

排除标准

  • Patients with less than 10 oocytes
  • Co-culture patients

研究组 & 干预措施

Global vs. G-TL Media

Experimental

Global medium will be compared with G-TL (Time-Lapse) medium.

干预措施: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media (Biological)

Global vs. Cornell's C3 Media

Experimental

Global medium will be compared with Cornell's C3 single step medium.

干预措施: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media (Biological)

Global vs. Cornell's sequential Media

Experimental

Global medium will be compared with Cornell's C1/C2 sequential medium.

干预措施: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media (Biological)

结局指标

主要结局

Embryo development

时间窗: Day 5

Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.

次要结局

  • Pregnancy rate(6 weeks)
  • Implantation rate(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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