跳至主要内容
临床试验/NCT07105891
NCT07105891进行中(未招募)不适用

Optimization of Oocyte Warming Protocols: a Comparative Study of Standard, Rapid, and Ultra-rapid Techniques on Oocyte Survival Rate and Spindle Morphometry

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 399 人开始时间: 2025年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
399
试验地点
2
主要终点
Oocytes Survival rate

研究概览

简要总结

This is a retrospective study with a sibling design comparing new oocyte thawing protocols (rapid and ultra-rapid) with the traditional method

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 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Vitrified oocytes from the Centro Scienze della Natalità, IRCCS San Raffaele Hospital
  • •Patients who explicitly consented to the disposal of their stored gametes and authorized their use for research purposes through the informed consent process
  • •Oocytes cryopreserved using the vitrification technique
  • •Patients age 20-39 yo

排除标准

  • •All oocytes cryopreserved using the slow freezing technique
  • •Oocytes from patients older than 40 years

研究组 & 干预措施

Standard

Other

Standard thawing

干预措施: Thawing protocol (Other)

Fast

Other

Fast thawing

干预措施: thawing protocol (Other)

Ultrafast

Other

Ultrafast thawing

干预措施: thawing protocol (Other)

结局指标

主要结局

Oocytes Survival rate

时间窗: 2 hours post-warming

Oocyte survival rate will be assessed 2 hours after thawing using morphological evaluation under a light microscope. Surviving oocytes will be identified by the presence of an intact zona pellucida and oolemma, a round shape, and homogeneous cytoplasm without signs of lysis, fragmentation, or cytoplasmic granulation.

次要结局

  • Chromosome distribution(2 hours post thawing)
  • Spindle configuration(2 hours post thawing)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Papaleo

MD

IRCCS San Raffaele

研究点 (2)

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