Clinical Validation of Ultra-rapid Blastocyst Vitrification: a Randomized Pilot Study in Oocyte Donation Cycles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Post-warming survival rate
研究概览
简要总结
Blastocyst vitrification is standard in assisted reproduction, but clinical data on ultra-rapid vitrification are limited. This pilot study evaluates the safety, feasibility, and preliminary clinical performance of an ultra-rapid blastocyst vitrification protocol compared with the standard approach.
详细描述
Blastocyst cryopreservation by vitrification is currently the standard approach in assisted reproductive technology, providing high post-warming survival rates and clinical outcomes comparable to those of fresh embryo transfer. Ongoing refinements of vitrification techniques aim to further improve laboratory efficiency and workflow while maintaining biological safety and clinical effectiveness.
Ultra-rapid vitrification protocols have been developed to shorten equilibration times by modifying exposure kinetics to cryoprotectants, while preserving the fundamental biophysical principles of vitrification. Although ultra-rapid warming protocols are well established, clinical data specifically evaluating ultra-rapid vitrification of blastocysts remain limited.
Moreover, ultra-rapid vitrification requires mechanical collapse of the blastocyst before cooling, introducing an additional embryological manipulation with potential biological implications that warrant careful clinical validation. In this context, the present pilot study aims to evaluate the safety, feasibility, and preliminary clinical performance of ultra-rapid blastocyst vitrification compared with the standard vitrification protocol, prior to broader clinical implementation.
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
- 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
- 否
入选标准
- •Recipients of donor oocytes
- •Blastocysts suitable for cryopreservation
排除标准
- •Cycles involving PGT
- •Cycles not reaching blastocyst stage.
结局指标
主要结局
Post-warming survival rate
时间窗: Immediately after warming (within the same laboratory session)
the proportion of vitrified blastocysts that remain morphologically viable after warming, expressed as a percentage of all warmed blastocysts.
Clinical pregnancy rate per transfer (only first transfer will be considered).
时间窗: 6-8 weeks after embryo transfer
defined as the proportion of embryo transfers resulting in a clinical pregnancy, confirmed by the presence of an intrauterine gestational sac on ultrasound. Only the first embryo transfer per patient is included in the analysis.
次要结局
- Blastocyst re-expansion(Within 2 hours after warming)
- Post-warming blastocyst morphokinetic parameters(From embryo warming until embryo transfer (within 2-6 hours post-warming))
- Post-warming blastocyst morphological quality(From embryo warming until embryo transfer (within 2-6 hours post-warming))
- Technical or embryological adverse events.(From blastocyst warming until embryo transfer, within the same clinical procedure (up to 6 hours post-warming))