Safety and Effectiveness of Freeze and Thaw Media Kits for the Manufacturing of Oocytes for Future Use in Assisted Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 8
- 主要终点
- Live birth
研究概览
简要总结
The purpose of this study is to determine the effectiveness of the ViaCell's product media for freezing and thawing human eggs for future use in assisted reproductive technology.
详细描述
ViaCell's product is an investigational product intended to broaden reproductive options for women through freezing and thawing of human eggs. The egg is a large cell with a high water content, historically making it difficult to freeze. It uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw eggs for future use.
Following informed consent, female subjects will be screened according to the inclusion/exclusion criteria of the protocol and eligible subjects will undergo hormonal stimulation using standard IVF drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Women 21-35 years of age
- •Women with male factor infertility seeking IVF treatment
- •Negative history of female infertility
- •Non-smoking for at least 1 year
排除标准
- •Greater than one miscarriage
- •More than one previous failed IVF attempt
结局指标
主要结局
Live birth
次要结局
未报告次要终点