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临床试验/NCT04085835
NCT04085835已完成不适用

Evolution and Genetic Basis of Menstruation in Women

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年10月27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
21
试验地点
1
主要终点
Gene expression levels measured by RNA-seq

研究概览

简要总结

This study examines gene expression and gene regulation in the uterine lining during menses in women, for evolutionary comparison with other primates which do or do not menstruate. Samples will be obtained by non-invasive collection of menstrual fluid from healthy donors.

详细描述

Menstruation corresponds to the shedding of the uterine lining when fecundation has not occurred. This is a recent evolutionary innovation in primates, and the cellular and genetic changes that led to the acquisition of menstruation are not well understood. Additionally, the uterine lining is poorly characterized in humans at the menstrual time point, which hinders both evolutionary and medically-relevant analyses.

In this study, the research team are collecting menstrual fluid samples from healthy female volunteers to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during menstruation. The investigators will compare this data to similar samples collected from other primates at the same time point in the female hormonal cycle.

The objective is to identify genes that have acquired novel regulation and/or expression patterns and which may be involved in menstruation.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • having regular periods
  • being comfortable using silicone menstrual hygiene devices ("cup")
  • having giving consent in writing

排除标准

  • use of an internal contraception method (hormone or non-hormone based) during or within three months before the study
  • pregnancy during or within three months before the study
  • amenorrhea (absent periods) during or within three months before the study
  • gynaecological intervention or surgery within three months before the study
  • hormonal treatment during or within three months before the study
  • absence of written consent
  • breastfeeding
  • medical treatment during the study
  • low (< 18.5) or high (> 30) body mass index (BMI)

结局指标

主要结局

Gene expression levels measured by RNA-seq

时间窗: Average to study completion 30 months

Gene expression levels measured in the different cell types of the endometrial tissue during menstruation using RNA extraction and sequencing (RNA-seq)

Active regulatory elements profiled by ATAC-seq

时间窗: Average to study completion 30 months

Profiling of the genetic elements accessible to transposase assays and sequencing (putative active regulatory elements; ATAC-seq) in the different cell types of endometrial tissue during menstruation

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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