跳至主要内容
临床试验/NCT06098495
NCT06098495招募中不适用

Looking for a Blood Epigenetic Signature to Predict Female Infertility

Università Vita-Salute San Raffaele1 个研究点 分布在 1 个国家目标入组 1,456 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,456
试验地点
1
主要终点
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART

研究概览

简要总结

The present research project aims to study the DNAm mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. Specifically, our project aims to build an epigenetic clock for MGCs by using outcomes that are certainly related to female fertility. The validation of such findings will be carried out on peripheral blood in order to guarantee its non-invasiveness and allow for any clinical transferability. In order to identify a blood epigenetic signature able to predict female infertility, we planned to explore the problem from different points of view by conducting several studies in different settings.

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 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18< age <43, Infertile woman undergoing ART, recurrent pregnancy loss

排除标准

  • age < 18 or > 44, previous ovarian surgery, severe male factor infertility

结局指标

主要结局

differences of DNA methylationin the peripheral venous blood of new patients undergoing ART

时间窗: 3 years

The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.

differences of DNA methylationin the peripheral venous blood of patients undergoing ART

时间窗: 3 years

search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients

differences of DNA methylation in granulosa cells of patients undergoing ART

时间窗: 3 years

The epigenetic profile of DNA extracted from granulosa cells of patients undergoing ART (COHORT1) will be examined to identify position and region's differences of DNA methylation in pregnant women (fertile women) and in who does not get pregnant (infertile women)

impact of exogenous pro-inflammatory factors

时间窗: 3 years

on all the above cohorts will be investigated, via online questionnaire

differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally

时间窗: 3 years

The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valeria Stella Vanni

Doctor

Università Vita-Salute San Raffaele

研究点 (1)

Loading locations...

相似试验