Looking for a Blood Epigenetic Signature to Predict Female Infertility (FIB_CARIPLO)

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.

Study Overview

• Status: Recruiting
• Conditions: Female Infertility
• Intervention / Treatment: Genetic: search for epigenetic profile of infertility

• Study Type: Observational
• Enrollment (Estimated): 1456

Contacts and Locations

• Study Contact: Name: Valeria Stella Vanni; Phone Number: +393476309895; Email: vanni.valeria@hsr.it

Study Locations

• Italy
  • Milano, Italy
    • Recruiting
    • Università Vita Salute San Raffaele
    • Contact: Valeria Stella Vanni; Phone Number: +393476309895; Email: vanni.valeria@hsr.it
    • Sub-Investigator: Sara D'Alessandro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Infertile woman undergoing ART, women affected by recurrent pregnancy loss, women attempting to conceive naturally

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
infertile women (unexplained, tubal, mild male factor); women belonging to couples selected for homologous IVF due to an unexplained, tubal or mild male factor
fertile women; women without any infertility history who are attempting to conceive naturally	Genetic: search for epigenetic profile of infertility; examine the epigenetic profile of DNA extracted from MGCs and blood sample
infertile women (ovarian factor); women selected for homologous IVF for different reason og chohort 1	Genetic: search for epigenetic profile of infertility; examine the epigenetic profile of DNA extracted from MGCs and blood sample
recurrent pregnancy loss; women affected by idiopathic recurrent pregnancy loss	Genetic: search for epigenetic profile of infertility; examine the epigenetic profile of DNA extracted from MGCs and blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differences of DNA methylation in granulosa cells of patients undergoing ART	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)	3 years
differences of DNA methylationin the peripheral venous blood of patients undergoing ART	search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients	3 years
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally	The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)	3 years
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART	The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.	3 years
impact of exogenous pro-inflammatory factors	on all the above cohorts will be investigated, via online questionnaire	3 years

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: FIB_CARIPLO_1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: publication of the results at the end of the trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No