Multicentric Clinical Trial to Improve Blastocyst Utilisation Rate (in Relation to 2 PN Embryos) by Group Culture of Human Embryos in WOW Dishes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- Blastocyst utilisation rate
研究概览
简要总结
In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos .
Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium.
In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.
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 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sperm obtained by ejaculation
- •Conventional IVF/ICSI
- •At least 10 fertilized oocytes (2 PN)
排除标准
- 未提供
研究组 & 干预措施
Individual culture
standard IVF protocol: half of the fertilized oocytes of the patient will be cultured individually in drops of 25 µl Cook cleavage medium till day 3 after fertilization and subsequently in drops of 25 µl Cook blastocyst medium till day 5 after fertilization
干预措施: control group (Other)
WOW
Half of the fertilized oocytes of the patient will be cultured in group in a WOW dish, each in a separate microwell but covered with one drop of 30 µl of Cook cleavage medium till day 3 after fertilization and subsequently all the embryos will be transferred to a new WOW dish (in the exactly the same position) covered with 30 µl of Cook blastocyst medium till day 5 after fertilization
干预措施: Primo Vision embryo culture dish (CE labeled, Vitrolife) (Device)
结局指标
主要结局
Blastocyst utilisation rate
时间窗: 5 days after fertilization
number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation)
次要结局
- Morphologic evaluation(5 days after fertilization)
- change in embryo development(at day 2, 3 and 4 after fertilization)
- life birth rate(9 months after embryo transfer)
- change in secretome(day 3 and day 5 after fertilization)
- pregnancy rate(day 15 and week 5 after embryo transfer)
