Automation of Oocyte and Embryo Vitrification: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Cryosurvival
研究概览
简要总结
Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff.
Background: Currently, freezing eggs and embryos during fertility treatments (IVF/ICSI) is done entirely by hand by skilled embryologists. This manual process is time-consuming, requires extensive training, and outcomes can vary between different staff members. Automating this process could help standardize procedures, reduce costs, and potentially make fertility treatments more accessible to patients.
What is Being Tested: The study will compare an automated freezing system (prototype designation PRESERVE-CR) against the standard manual freezing method. The key research question is: Can the automated system preserve eggs and embryos as successfully as experienced embryologists do by hand?
How It Works: Patients undergoing IVF/ICSI treatment at CARE Fertility Manchester who consent to participate will have their surplus eggs and embryos (those not suitable for their treatment) divided into two groups. Some will be frozen using the traditional manual method, and some using the new automated system. Both groups will then be thawed to measure survival rates. Tests do not encompass any reproductive outcomes or the creation of embryos specifically for this research.
Why This Matters: If successful, automated freezing could help reduce the workload on laboratory staff, standardize the freezing process across different clinics, potentially lower treatment costs, and make fertility treatments available to more people who need them. The study only uses oocytes and embryos which are unsuitable for patient treatment and that would otherwise be discarded, ensuring no impact on participants' actual fertility treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: Between 20-35 kg/m²
- •Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
排除标准
- •Low ovarian reserve
- •Surgical sperm retrieval required
结局指标
主要结局
Cryosurvival
时间窗: Within 14 days of egg retrieval
The proportion of eggs and embryos that survive the freezing and thawing process when using the PRESERVE-CR automated system compared to manual vitrification (sibling controls).
Cryosurvival
时间窗: Within 14 days of egg retrieval
The proportion of eggs and embryos that survive the freezing and thawing process when using the PRESERVE-CR automated system compared to manual vitrification (sibling controls).
次要结局
- Procedural Timing(Within 14 days of egg retrieval.)
- Morphological Quality Assessment(Within 14 days of egg retrieval)
- Technical Performance Metrics(Within 14 days of egg retrieval.)
- Procedural Timing(Within 14 days of egg retrieval.)
- Morphological Quality Assessment(Within 14 days of egg retrieval)
- Technical Performance Metrics(Within 14 days of egg retrieval.)
