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