Looking for a Blood Epigenetic Signature to Predict Female Infertility

NCT ID: NCT06098495

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-16

Study Completion Date

2026-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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Female Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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infertile women (ovarian factor)

women selected for homologous IVF for different reason og chohort 1

search for epigenetic profile of infertility

Intervention Type GENETIC

examine the epigenetic profile of DNA extracted from MGCs and blood sample

infertile women (unexplained, tubal, mild male factor)

women belonging to couples selected for homologous IVF due to an unexplained, tubal or mild male factor

No interventions assigned to this group

fertile women

women without any infertility history who are attempting to conceive naturally

search for epigenetic profile of infertility

Intervention Type GENETIC

examine the epigenetic profile of DNA extracted from MGCs and blood sample

recurrent pregnancy loss

women affected by idiopathic recurrent pregnancy loss

search for epigenetic profile of infertility

Intervention Type GENETIC

examine the epigenetic profile of DNA extracted from MGCs and blood sample

Interventions

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search for epigenetic profile of infertility

examine the epigenetic profile of DNA extracted from MGCs and blood sample

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Valeria Stella Vanni

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Università Vita Salute San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valeria Stella Vanni

Role: CONTACT

+393476309895

Facility Contacts

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Valeria Stella Vanni

Role: primary

+393476309895

Other Identifiers

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FIB_CARIPLO_1.0

Identifier Type: -

Identifier Source: org_study_id

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