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临床试验/NCT02457481
NCT02457481已完成不适用

An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro

National Foundation for Fertility Research4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
4
主要终点
embryo development

研究概览

简要总结

The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.

详细描述

Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
  • Patients can be of any race, culture, sexual orientation or ethnicity.

排除标准

  • Minors are excluded from the study

研究组 & 干预措施

Embryo Culture medium

Experimental

Embryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium).

干预措施: Embryo Culture medium (Device)

结局指标

主要结局

embryo development

时间窗: 7 days after egg retrieval

Blastocyst development and quality on days 5 and 6 of culture

pregnancy rate

时间窗: 2 months after egg retrieval

The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.

offspring gender

时间窗: 1 year after egg retrieval

The gender of children born

offspring weight

时间窗: 1 year after egg retrieval

The birth weight of children born

次要结局

  • euploid embryos(1 month after egg retrieval)
  • fertilization(2 days after egg retrieval)

研究者

发起方
National Foundation for Fertility Research
申办方类型
Other
责任方
Sponsor

研究点 (4)

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