NCT00985218已完成1 期
In Vitro Human Embryo Culture System
Incept BioSystems, Inc.8 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- rate of development of human embryos
研究概览
简要总结
The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.
详细描述
This study is a multi-center, randomized, performance study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:
- •Female 21 to 35 years of age inclusive
- •First or second IVF cycle
- •Not pregnant
- •No physical abnormalities that would adversely affect oocyte retrieval
- •Male factor is acceptable
- •ICSI is acceptable
- •10 zygotes or more
排除标准
- •Potential subjects are excluded from the study if any of the following conditions exist:
- •The sperm were retrieved using TESE or MESA
- •The embryos were created with either donor oocytes or donor sperm.
- •Medical condition precluding a safe pregnancy
- •Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator
结局指标
主要结局
rate of development of human embryos
时间窗: Day 3 (t=72 hrs)
次要结局
未报告次要终点
研究者
研究点 (8)
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