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Could AI and genetics finally crack endometriosis diagnosis?

NCT ID NCT06572852

Knowledge-focused Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study is recruiting 530 women to better understand endometriosis and adenomyosis. Researchers will analyze genetic, epigenetic, and imaging data, using artificial intelligence to develop better diagnostic tools. The goal is to enable earlier detection and more personalized treatment for these painful conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better, earlier diagnostic tools for endometriosis and adenomyosis, potentially improving treatment and fertility outcomes.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care, and the findings might not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 530 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will involve a total of 530 participants selected from two Assisted Reproduction Centers. The participant population includes: * Group A: 100 women diagnosed with both endometriosis and adenomyosis (cases). * Group B: 15 women diagnosed exclusively with endometriosis (cases). * Group C: 15 women diagnosed exclusively with adenomyosis (cases). * 400 women from couples seeking fertility treatment at infertility clinics (controls). Additionally, Group D will consist of 300 DNA biobank samples from women diagnosed with endometriosis.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adenomyosis endometriosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenomyosis Endometriosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro

    ACTIVE_NOT_RECRUITING

    Catanzaro, Catanzaro, 88100, Italy

  • IRCCS San Raffaele Hospital

    RECRUITING

    Milan, Milano, 20132, Italy

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