Looking for a Blood Epigenetic Signature to Predict Female Infertility
ConditionFemale Infertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-43
SponsorUniversità Vita-Salute San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18< age <43, Infertile woman undergoing ART, recurrent pregnancy loss
Disqualifiers
age < 18 or > 44, previous ovarian surgery, severe male factor infertility
Trial population
Infertile woman undergoing ART, women affected by recurrent pregnancy loss, women attempting to conceive naturally
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
search for epigenetic profile of infertility
Geneticexamine the epigenetic profile of DNA extracted from MGCs and blood sample
Treatment groups
1,456 Participants
are divided into 4 treatment groupsGroup A: infertile women (unexplained, tubal, mild male factor)0 interventions
Group B: fertile women1 intervention
Group C: infertile women (ovarian factor)1 intervention
Group D: recurrent pregnancy loss1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
3 years2
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
Time frame
3 years3
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)
Time frame
3 years4
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.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov