Comparative Study of Two Embryo Culture Systems: Randomization of Attempts at In Vitro Fertilization With ICSI at the Centre for Medically Assisted Procreation at Dijon CHU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Implantation rate
研究概览
简要总结
The centre for Medically-Assisted Procreation (MAP) of Dijon CHU has two high-technology embryo culture systems, with incubation characteristics that are potentially superior to those provided by classical culture systems. Indeed, these two systems, available in only two MAP centres in France, make it possible to maintain a stable temperature and gaseous environment during the in-vitro development of the embryos.
It is necessary to observe the development of the embryos to determine which embryos have the highest implantation potential. These observations are done from time to time by microscope for one system and continuously using an incorporated video camera for the other (cinematographic study). The MAP centre in Dijon wishes to compare the interest of these two systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons who have provided oral consent
- •Attempt at In Vitro Fertilization with ICSI (IntraCytoplasmic Sperm Injection)
- •At least 6 mature ovocytes to microinject
排除标准
- •Persons not covered by national health insurance
- •Attempt at In Vitro Fertilization (IVF)
- •Fewer than 6 mature ovocytes
- •Decision to transfer at the zygote stage during the multidisciplinary meeting
- •Attempts made in a context of viral risk (both systems are in a virus risk-free zone)
- •Attempts with surgically-harvested spermatozoa
研究组 & 干预措施
Embryoscope group
干预措施: Embryoscope (Device)
Embryo culture without incorporated camera group
干预措施: Embryo culture system without incorporated camera (Device)
结局指标
主要结局
Implantation rate
时间窗: 16 weeks after transfer
The implantation rate is defined as the number of embryos implanted (gestational sacs seen on the US scan) compared to the total number of embryos transferred.
次要结局
- Rate of miscarriages(16 weeks after transfer)