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临床试验/NCT00910390
NCT00910390已完成不适用

Randomized Comparison to Freeze Human Embryos by Either Vitrification or Slow Freezing Protocols

Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 584 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
584
试验地点
2
主要终点
Survival embryo rate

研究概览

简要总结

This randomized study compares three different freezing methods to store human in vitro fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After information, all patients undergoing IVF treatment can be included in the study. If qualified, embryos at different developmental stages will be allocated between the three methods. At the end of the first year survival and developmental rates, and implantation and pregnancy rates will be analyzed in order to determine the best method.

详细描述

Despite all the advances achieved in vitro fertilized treatments, it is known that the chances of implantation for fertilised in vitro embryo remain limited, at around 20%. Cryopreservation of supernumerary embryos produced during IVF cycles provides an opportunity for patients to increase the number of transfers per oocyte harvest cycle, increasing then their chances of conception.

The freezing technique may involve different media and methods, which lead to different survival and developmental rates after thawing.

Vitrification is a new freezing method, which consists in exposing cells to high concentrations of cryoprotectants and then cooling them ultra-rapidly; this induces an increase in viscosity which favours the formation of a vitreous state without any ice crystals formation. This method contrasts with the slow freezing method (currently employed), which is based on exposure to very low concentrations of cryoprotectants combined with long cooling times and associated with a higher risk of ice crystal formation.

Both methods can reduce cell survival and embryo ability to develop, either by the high concentrations of cryoprotectants in case of vitrification, or by ice crystals formation in case of slow freezing. The advantages of vitrification in embryology may be considerable because embryos seem more sensitive to ice crystal formation than to cyroportectant concentration; consequently, the elimination of office crystal injury may increase their survival chances. Additionally in the case of vitrification, the time required for equilibration and cooling is considerably reduced as well as the need for expensive equipment such as programmable machine is eliminated.

At present, vitrification and slow freezing are used for the cryopreservation of oocytes and embryos at all stages of development. Encouraging results have been obtained with vitrification, but no study has randomly compared in one study, the two protocols and cryoprotectors. The purpose of this clinic randomised study is to compare three treatments: traditional slow freezing method currently employed (control group) and two different commercial vitrification methods (experimental groups) to assess the efficacy that this technique may involve.

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 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Infertility requiring IVF

排除标准

  • Women's age > 43 years
  • Patients positive for hepatitis B or C
  • Patients positive for HIV

结局指标

主要结局

Survival embryo rate

时间窗: one year

次要结局

  • Delivery rate(one year)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fasano Giovanna

Clinical Embryologist

Erasme University Hospital

研究点 (2)

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