FIB_CARIPLO: Looking for a Blood Epigenetic Signature to Predict Female Infertility

Sponsor
Università Vita-Salute San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT06098495
Collaborator
(none)
1,456
1
36
40.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: search for epigenetic profile of infertility

Study Design

Study Type:
Observational
Anticipated Enrollment :
1456 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Looking for a Blood Epigenetic Signature to Predict Female Infertility
Actual Study Start Date :
Oct 16, 2023
Anticipated Primary Completion Date :
Oct 16, 2026
Anticipated Study Completion Date :
Oct 16, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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

  3. 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)

  4. 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.

  5. impact of exogenous pro-inflammatory factors [3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 43 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Università Vita Salute San Raffaele Milano Italy

Sponsors and Collaborators

  • Università Vita-Salute San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valeria Stella Vanni, Doctor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT06098495
Other Study ID Numbers:
  • FIB_CARIPLO_1.0
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2023