Status:
RECRUITING
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
AUO Renato Dulbecco
Conditions:
Endometriosis
Adenomyosis
Eligibility:
FEMALE
18-40 years
Brief Summary
This study is a multicentric, observational, case-control, non-profit with additional procedures. It aims to deepen the understanding of the chronic gynecological conditions of endometriosis and adeno...
Detailed Description
Recent research indicates that epigenetic blood analysis could revolutionize the diagnosis of endometriosis, moreover, strong correlations between endometrial and blood methylation have been reported,...
Eligibility Criteria
Inclusion
- Participants eligible for cases with endometriosis and adenomyosis, must meet the following criteria:
- Able to give informed consent for participation in the study.
- European descent.
- Confirmed diagnosis of both endometriosis and adenomyosis through ultrasound screening.
- Listed for assisted reproductive treatment, specifically within their first or second IVF cycle.
- Participants eligible for cases with only endometriosis must meet the following criteria:
- Able to give informed consent for participation in the study.
- European descent.
- Confirmed diagnosis of endometriosis with no ultrasound evidence of adenomyosis.
- Enrolled in an assisted reproductive treatment cycle involving embryo thawing.
- Participants eligible for cases with only adenomyosis must meet the following criteria:
- Able to give informed consent for participation in the study.
- European descent.
- Confirmed diagnosis of adenomyosis with no ultrasound evidence of endometriosis.
- Enrolled in an assisted reproductive treatment cycle involving embryo thawing.
- Participants eligible as controls must meet the following criteria:
- Able to give informed consent for participation in the study.
- European descent.
- Undergone ultrasound screenings that have excluded the presence of endometriosis or adenomyosis.
- Listed for assisted reproductive treatment, specifically within their first or second IVF cycle.
- Presence of reduced ovarian reserve or non-severe male factor infertility.
Exclusion
- Patients unable or unwilling to sign the informed consent
- Individuals who exhibit the presence of sactosalpinx or other uterine pathologies such as fibroids, polyps, or irregular endometrial thickening will be excluded from participation in this study.
- These exclusion criteria are applicable across all groups to ensure the accuracy and reliability of the study's findings related to endometriosis and adenomyosis.
Key Trial Info
Start Date :
November 7 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT06572852
Start Date
November 7 2024
End Date
August 30 2026
Last Update
October 7 2025
Active Locations (2)
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1
Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro
Catanzaro, Catanzaro, Italy, 88100
2
IRCCS San Raffaele Hospital
Milan, Milano, Italy, 20132