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Looking for a Blood Epigenetic Signature to Predict Female Infertility

Looking for a Blood Epigenetic Signature to Predict Female Infertility

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06098495
Acronym
FIB_CARIPLO
Enrollment
1456
Registered
2023-10-24
Start date
2023-10-16
Completion date
2026-10-16
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

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.

Interventions

GENETICsearch for epigenetic profile of infertility

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

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
differences of DNA methylation in granulosa cells of patients undergoing ART3 yearsThe 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 patients undergoing ART3 yearssearch for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally3 yearsThe specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART3 yearsThe specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.
impact of exogenous pro-inflammatory factors3 yearson all the above cohorts will be investigated, via online questionnaire

Countries

Italy

Contacts

Primary ContactValeria Stella Vanni
vanni.valeria@hsr.it+393476309895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026