Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With a Positive bHCG Level as Detected by a Blood Test
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.
详细描述
Following randomization and standard ovarian stimulation protocols to obtain a sufficient number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm Injection (ICSI). If a patient has been randomized to the study group, all inseminated oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen embryo transfer cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Women undergoing in vitro fertilization treatment using their own or frozen oocytes
- •Fresh or Frozen Embryo Transfer
- •Fertilization by ICSI
- •At least 4 diploid (2PN) embryos at fertilization check
- •Willing to have all inseminated oocytes imaged by Miri
- •Willing to comply with study protocol and procedures Willing to provide written informed consent
排除标准
- •Fertilization using surgically removed sperm
- •History of cancer
研究组 & 干预措施
Control Incubator
Standard Incubator
MIRI-TL Timelapse Incubator
Timelapse incubator
干预措施: MIRI-TL Incubator (Device)
Culture Coin Dish
Culture Coin dish for embryo culture
干预措施: MIRI-TL Incubator (Device)
Control dish
Control Dish for embryo culture
结局指标
主要结局
Number of Participants With a Positive bHCG Level as Detected by a Blood Test
时间窗: 14 days after embryo transfer
Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level \>50mIU/mL is considered to be a successful pregnancy.
次要结局
- Number of Patients With Embryo Implantation(28 days)
- Embryo Development(7 days)