Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorIRCCS San Raffaele

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

530 Participants
are divided into 5 treatment groups

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

AUO Renato Dulbecco

Collaborator