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Recruiting NCT06098495

Looking for a Blood Epigenetic Signature to Predict Female Infertility

Observational Female Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: search for epigenetic profile of infertility.
Who it may be relevant to
Registry conditions: Female Infertility. Basic parameters: 18 years — 43 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Genetic search for epigenetic profile of infertility
    examine the epigenetic profile of DNA extracted from MGCs and blood sample

Primary outcome measures

  • differences of DNA methylation in granulosa cells of patients undergoing ART [Time frame: 3 years]
  • differences of DNA methylationin the peripheral venous blood of patients undergoing ART [Time frame: 3 years]
  • differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally [Time frame: 3 years]
  • differences of DNA methylationin the peripheral venous blood of new patients undergoing ART [Time frame: 3 years]
  • impact of exogenous pro-inflammatory factors [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Università Vita Salute San Raffaele — Milan

Identifiers

NCT: NCT06098495 · FIB_CARIPLO_1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗