Bases évolutives et Fonctionnelles de la Menstruation Chez Les Femmes - 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Transcriptomics
研究概览
简要总结
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 across the menstrual cycle, which hinders both evolutionary and medically-relevant analyses.
In this study, the research team are collecting uterine endometrial tissue samples from female donors undergoing uterine surgery for benign conditions, to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during the secretive phase of the menstrual cycle. 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, as well as better characterize the cellular and molecular pathways at work in the uterine lining of women for translational medicine purposes.
详细描述
Collection:
The research team will collect endometrial biopsies or discarded tissue scraps from medical practice from 20 consenting female donors undergoing surgical hysteroscopy for benign uterine conditions.
Primary objective:
The research team will perform transcriptome sequencing and open chromatin profiling from the tissue samples and compare to similar data produced from non-human primates that either do or do not menstruate. They will identify and characterize genes and non-coding regulatory elements differentially used in menstruating species and involved in the evolution of menstruation.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 50 years old.
- •Have mensturation at the time of their participation
- •Have given their written consent
- •Have an indication for surgery of hysteroscopy for removal of a polyp and/or fibroid and/or endometrial, endometrialctomy for presumed benign pathology and/or management of a uterine malformation, scheduled between days 21 and 25 of their menstrual cycle
- •Covered by social security
排除标准
- •Using an intrauterine device contraceptive method during the study or within the previous three months
- •To be Pregnant at the time of collection
- •Have been pregnant in the three months prior to collection
- •Have had amenorrhoea in the three months prior to collection
- •Have received hormonal treatment within the three months prior to collection
- •Have participated in a clinical study within 3 months prior to collection
- •Have a personal history of breast, ovarian, body or cervical cancer
- •Have a diagnosis of endometriosis
- •Have a diagnosis of adenomyosis
- •Have a diagnosis of Lynch syndrome
- •Undergoing hysteroscopy for a condition other than those listed in the inclusion criteria
- •Women who have not given written consent
- •Women who are breastfeeding
- •Women with a body mass index (BMI) of less than 18.5 or more than 30
研究组 & 干预措施
Main cohort
This is a single-arm study. Samples are collected from consenting donors undergoing surgery for medical purposes.
干预措施: Hysteroscopy (Procedure)
结局指标
主要结局
Transcriptomics
时间窗: 18 months
Characterisation of genes involved in the evolutionary establishment of menstruation: transcriptome sequencing and identification of genes differentially expressed between menstruating and non-menstruating species in each cell type using DeSEQ analysis (FDR-corrected p-value \< 0.05)
Open chromatin analysis
时间窗: 18 months
Characterisation of non-coding regulatory elements specifically involved in the evolutionary establishment of menstruation: open chromatin sequencing (ATAC-seq) and identification of non-coding genomic regions differentially activated between menstruating and non-menstruating species in each cell type using DeSEQ analysis (FDR-corrected p-value \< 0.05)
次要结局
- Non-coding transcriptomics(18 months)
- 3D cell culture - establishment(18 months)
- 3D cell culture - structural evaluation(18 months)
- 3D cell culture - cell types evaluation(18 months)
- 3D cell culture - gene expression(18 months)