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临床试验/NCT03416400
NCT03416400Unknown不适用

Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes

研究概览

简要总结

Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.

To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.

详细描述

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - ICSI treatment
  • Immature oocytes
  • < 37 years old

排除标准

  • - Polyckistic Ovarian Syndrome
  • Endometriosis
  • Ovulatory disease

结局指标

主要结局

Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes

时间窗: at day 1

After oocytes retrieval, immature oocytes will be vitrified (Rapid Vit Ovocyte®, Vitrolife) in a closed system (Rapid-I®, Vitrolife) and thawed for in vitro maturation few days after. The meiotic process will be analyzed by time lapse technology (Primovision®, Vitrolife). This will permit to score the time of maturation from resumption to polar body extrusion of ovocytes.

次要结局

  • Analysis of actin and tubulin cytoskeleton at Metaphase-II stage(at day 1)
  • Analysis of cortical granules distribution in Metaphase-II stage oocytes.(at day 1)
  • Analysis of maternal factor stabilities.(at day 1)
  • Analysis of chromosome segregation during the first meiotic division.(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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