Looking for a Blood Epigenetic Signature to Predict Female Infertility

Female Infertility Clinical Trial

— FIB_CARIPLO  

Official title:

Looking for a Blood Epigenetic Signature to Predict Female Infertility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098495
• Other study ID #: FIB_CARIPLO_1.0
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: October 16, 2026

Study information

• Verified date: October 2023
• Source: Università Vita-Salute San Raffaele
• Contact: Valeria Stella Vanni
• Phone: +393476309895
• Email: vanni.valeria[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1456
• Est. completion date: October 16, 2026
• Est. primary completion date: October 16, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Italy	Università Vita Salute San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 years
Primary	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	3 years
Primary	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)	3 years
Primary	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.	3 years
Primary	impact of exogenous pro-inflammatory factors	on all the above cohorts will be investigated, via online questionnaire	3 years