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临床试验/NCT01745536
NCT01745536撤回不适用

"Impact of a Closed System in Donor Oocyte Vitrification"

Instituto Valenciano de Infertilidad, IVI VALENCIA4 个研究点 分布在 1 个国家开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
4
主要终点
Survival after oocyte vitrification using the closed device Cryotop®

研究概览

简要总结

This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

详细描述

The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • < 35 years old
  • Normal physical and gynecological examinations
  • No family history of hereditary or chromosomal diseases.
  • Normal karyotype
  • Negative screening for sexually transmitted diseases.
  • Oocyte recipients:
  • Oocyte recipients < 50 years old
  • Body mass index < 30
  • < 2 previous IVF failures
  • No severe male factor
  • No recurrent miscarriage
  • No hidrosalpinx
  • No adenomyosis
  • No AMH alterations

排除标准

  • Donors and recipients not meeting inclusion criteria

结局指标

主要结局

Survival after oocyte vitrification using the closed device Cryotop®

时间窗: >2 hours

Survival will be evaluated morphologically two hours after warming.

次要结局

  • Embryo development(From thawing and until pregnancy outcome (0-9 months))

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Cobo

Cryo-biology Unit director at IVI Valencia, Spain

Instituto Valenciano de Infertilidad, IVI VALENCIA

研究点 (4)

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