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NCT Number: NCT06098495

Looking for a Blood Epigenetic Signature to Predict Female Infertility

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Università Vita Salute San Raffaele

Milan, Italy

Location status: Recruiting

Location contact

Sara D'Alessandro

SUB_INVESTIGATOR

Valeria Stella Vanni

CONTACT

[email protected]

+393476309895

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

search for epigenetic profile of infertility

Genetic

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

Primary outcomes

  1. differences of DNA methylation in granulosa cells of patients undergoing ART

    Time frame: 3 years

    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)

  2. differences of DNA methylationin the peripheral venous blood of patients undergoing ART

    Time frame: 3 years

    search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients

  3. differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally

    Time frame: 3 years

    The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)

  4. differences of DNA methylationin the peripheral venous blood of new patients undergoing ART

    Time frame: 3 years

    The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.

  5. impact of exogenous pro-inflammatory factors

    Time frame: 3 years

    on all the above cohorts will be investigated, via online questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Valeria Stella Vanni

CONTACT

[email protected]

+393476309895

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Acronym: FIB_CARIPLO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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