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临床试验/NCT02171884
NCT02171884已完成不适用

Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2013年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
298
试验地点
2
主要终点
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)

研究概览

简要总结

For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.

Participation consists in accepting samples to be taken at the birth of the infant:

  1. from the umbilical cord.
  2. from the placenta.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients who have provided written informed consent,
  • Patients with national health insurance cover,
  • Maternal age at conception between 20 and 43 years,
  • Paternal age at conception between 18 and 50 years,
  • Singleton pregnancy

排除标准

  • --Maternal disease:
  • pulmonary, cardiac
  • renal and metabolic diseases (including type 1 and 2 diabetes prior to the pregnancy)
  • systemic inflammatory diseases
  • hypertension
  • neurological diseases
  • chronic hepatitis B or C
  • HIV infection

结局指标

主要结局

Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)

时间窗: Baselines

DNA / RNA extraction

Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)

时间窗: Baselines

DNA / RNA extraction

Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)

时间窗: Baselines

DNA / RNA extraction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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