Comparative Study Between Two Systems of Gamete and Embryo Handling: Closed Environment Versus Open System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Embryo quality
研究概览
简要总结
There is not yet a standardized system of human embryonic culture in vitro. In addition, technical improvements continually appear. The investigators recently carried out a study in which it shows that the grouped embryo culture at low oxygen tension (5% O2) in a benchtop incubator shows better success rates than individual culture at atmospheric oxygen tension (20% O2) in a conventional incubator. For these reasons, the investigators have decided to continue this research line to evaluate the efficacy of a new ART station with a closed environment in comparison of an open flow cabinet. This new system keeps a controled environment maintaining a carbon dioxide (CO2) concentration of 6% and a temperature of 37 degrees. A prospective randomized study will be carried out in which the manipulation of the gametes and pre-embryos of the patients will be carried out in open laminar flow cabinets or in a closed station that maintain the CO2 and temperature conditions.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing a written consent to participate in the study.
- •Blastocyst transfer:
- •Patients using their own oocytes under 40 years.
- •Patients using donated oocytes.
排除标准
- •Preimplantation genetic screening patients.
- •Severe male factor (spermatozoa of testicular or epididymal origin, patients with cryptozoospermia and patients with retrograde ejaculation)
结局指标
主要结局
Embryo quality
时间窗: Through study completion, an average of two years
Rate of viable embryos = Transferred and Frozen embryos / Total number of embryos obtained
次要结局
- Live birth rate of the first cycle per transferred embryo(Through study completion, an average of two years)
- Implantation rate(Through study completion, an average of two years)
- Live birth rate per first embryo transfer(Through study completion, an average of two years)
- Cumulative live birth rate(Through study completion, an average of two years)