Improving diagnosis of endometriosis and adenomyosis using advanced analysis techniques
Official title: Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
Run by IRCCS San Raffaele · NCT06572852 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 530 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 2 sites (Catanzaro, Catanzaro and 1 other locations) |
| Status | Recruiting |
| Started | November 7, 2024 |
| Main results expected | February 28, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT06572852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
IRCCS San Raffaele Hospital
Milan, Milano, Italy Recruiting -
Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro
Catanzaro, Catanzaro, Italy Active not recruiting
Study contacts
- Principal investigator: Massimo Candiani — IRCCS San Raffaele
- Study coordinator: Luca Pagliardini
- Email: pagliardini.luca@hsr.it
- Phone: 0226434834
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cannabinoid-based product for gynecologic pain in endometriosis, adenomyosis, or PID
This study tests a high-CBD, hemp-derived product against placebo in adults with gynecologic pain from endometriosis, adenomyosis, or PID over one week to see if it reduces pain and related symptoms.
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Good pain consultation for endometriosis
This trial will test whether adding a 'good pain consultation' with early biopsychosocial pain education to usual care helps biological women with endometriosis manage pain and improve quality of life.
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Effects of pelvic organ diseases on endometrial receptivity in infertile women
This study is trying to see how conditions like adenomyosis, fibroids, and endometriosis affect the ability of the uterus to support pregnancy in women who are having trouble getting pregnant.
-
Measuring L-PGDS levels in blood, urine, vaginal fluid and endometrial tissue
This project will test whether L-PGDS levels in blood, urine, vaginal fluid and uterine tissue differ between women with adenomyosis, other benign uterine conditions, and healthy controls.
-
Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
-
Investigating the effects of diet and therapy on endometriosis pain
This study is testing whether an anti-inflammatory diet and therapy can help women with endometriosis feel less pain and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.