Looking for a Blood Epigenetic Signature to Predict Female Infertility

Recruiting

• Conditions: Female Infertility

• Registration Number: NCT06098495
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-16
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2026-10-16
• Study Completion: 2026-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1456

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
impact of exogenous pro-inflammatory factors	3 years	on all the above cohorts will be investigated, via online questionnaire
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART	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	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	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)
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally	3 years	The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)

Trial Locations

Locations (1)

Università Vita Salute San Raffaele; 🇮🇹 Milano, Italy