NCT06572852 Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
| NCT ID | NCT06572852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 530 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 530 participants in total. It began in 2024-11-07 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 adenomyosis, which significantly impact women's reproductive health. Its purpose is to improve early diagnosis and personalized treatment of these conditions using a multi-omic approach, that integrates genetic, epigenetic, imaging, and endometrial receptivity data. The goal is also to refine image-based predictions through recent advancements in artificial intelligence and to study uterine extracellular vesicles to assess fertility non-invasively. The study targets patients with endometriosis and/or adenomyosis and involves women seeking fertility treatments at assisted reproduction centers, who will serve as a control population. The study comprises both prospective and retrospective components. The prospective recruitment involves the collection of blood and uterine fluid samples, while the retrospective element utilizes pre-existing biobank samples for comprehensive genetic and epigenetic analysis.
Eligibility 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.
Contact & Investigator
MASSIMO CANDIANI
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT06572852 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06572852 currently recruiting?
Yes, NCT06572852 is actively recruiting participants. Contact the research team at pagliardini.luca@hsr.it for enrollment information.
Where is the NCT06572852 trial being conducted?
This trial is being conducted at Catanzaro, Italy, Milan, Italy.
Who is sponsoring the NCT06572852 clinical trial?
NCT06572852 is sponsored by IRCCS San Raffaele. The principal investigator is MASSIMO CANDIANI at IRCCS San Raffaele. The trial plans to enroll 530 participants.