Clinical trial
Looking for a Blood Epigenetic Signature to Predict Female Infertility
Name
FIB_CARIPLO_1.0
Description
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.
Trial arms
Trial start
2023-10-16
Estimated PCD
2026-10-16
Trial end
2026-10-16
Status
Recruiting
Treatment
search for epigenetic profile of infertility
examine the epigenetic profile of DNA extracted from MGCs and blood sample
Arms:
fertile women, infertile women (ovarian factor), recurrent pregnancy loss
Size
1456
Primary endpoint
differences of DNA methylation in granulosa cells of patients undergoing ART
3 years
differences of DNA methylationin the peripheral venous blood of patients undergoing ART
3 years
differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally
3 years
differences of DNA methylationin the peripheral venous blood of new patients undergoing ART
3 years
impact of exogenous pro-inflammatory factors
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample, Oocyte granulosa cells'}, 'enrollmentInfo': {'count': 1456, 'type': 'ESTIMATED'}}
Updated at
2023-10-24
1 organization
1 product
1 indication
Organization
Università Vita-Salute San RaffaeleIndication
Infertility