Looking for a Blood Epigenetic Signature to Predict Female Infertility

NCT06098495 | Recruiting DMC

• 1 other identifier: FIB_CARIPLO_1.0
• Study Type: observational
• Target: 1,456
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

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

infertile women (ovarian factor)

women selected for homologous IVF for different reason og chohort 1

Genetic: search for epigenetic profile of infertility

recurrent pregnancy loss

women affected by idiopathic recurrent pregnancy loss

Genetic: search for epigenetic profile of infertility

Interventions

search for epigenetic profile of infertility GENETIC

examine the epigenetic profile of DNA extracted from MGCs and blood sample

fertile women; infertile women (ovarian factor); recurrent pregnancy loss

Eligibility Criteria

• Age: 18 Years - 43 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Università Vita Salute San Raffaele

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, Oocyte granulosa cells

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Valeria Stella Vanni

CONTACT

+393476309895; vanni.valeria@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)