NCT02141685Unknown不适用
Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Eeva time-lapse parameters and aCGH testing results
研究概览
简要总结
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.
详细描述
The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is ≤43 years of age.
- •Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs.
- •Antral Follicle Count ≥ 6 at time of cycle start
- •Baseline (day 2-3 of cycling) FSH ≤ 15 mIU/ml
- •Antimüllerian Hormone level ≥ 0.5 ng/mL
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- •Willing to have all 2PN embryos monitored by Eeva
- •Not previously enrolled in this study.
- •Willing to comply with study protocol and procedures and able to speak English.
- •Willing to provide written informed consent.
排除标准
- •Prior IVF cycle with < 4 x 2PN
- •Planned Day 3 Assisted Hatching
结局指标
主要结局
Eeva time-lapse parameters and aCGH testing results
时间窗: 5-6 days
Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results
次要结局
- Embryo Implantation Rate(6 weeks)
- Clinical Pregnancy Rate(6 weeks)
- Ongoing pregnancy rate(8-12 weeks)
研究者
研究点 (1)
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