Improving diagnosis of endometriosis and adenomyosis using advanced analysis techniques
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
This study is trying to find better ways to diagnose endometriosis and adenomyosis in women by using advanced techniques that look at genetics and imaging to help personalize treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 530 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 2 sites (Catanzaro, Catanzaro and 1 other locations) |
| Trial ID | NCT06572852 on ClinicalTrials.gov |
What this trial studies
This multicentric observational study aims to enhance the understanding and diagnosis of endometriosis and adenomyosis, chronic gynecological conditions affecting women's reproductive health. By employing a multi-omic approach that integrates genetic, epigenetic, imaging, and endometrial receptivity data, the study seeks to refine diagnostic methods and personalize treatment options. It involves both prospective and retrospective components, collecting blood and uterine fluid samples from women undergoing fertility treatments, while also utilizing artificial intelligence for image-based predictions. The goal is to identify specific biomarkers and improve early diagnosis of these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are women of European descent with confirmed diagnoses of endometriosis and/or adenomyosis who are seeking assisted reproductive treatments.
Not a fit: Patients who do not have endometriosis or adenomyosis, or those not of European descent, may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of endometriosis and adenomyosis, ultimately improving treatment outcomes for affected women.
How similar studies have performed: Other studies have shown promise in using multi-omic approaches and AI for diagnosing similar conditions, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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.
Where this trial is running
Catanzaro, Catanzaro and 1 other locations
- Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro — Catanzaro, Catanzaro, Italy (Active_not_recruiting)
- IRCCS San Raffaele Hospital — Milan, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Candiani — IRCCS San Raffaele
- Study coordinator: Luca Pagliardini
- Email: pagliardini.luca@hsr.it
- Phone: 0226434834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.