Actively Recruiting
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
Led by IRCCS San Raffaele · Updated on 2025-10-07
530
Participants Needed
2
Research Sites
94 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
A
AUO Renato Dulbecco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent for participation in the study
- Of European descent
- Confirmed diagnosis of both endometriosis and adenomyosis through ultrasound screening and listed for assisted reproductive treatment within their first or second IVF cycle (for combined cases)
- Confirmed diagnosis of endometriosis only with no ultrasound evidence of adenomyosis and enrolled in an assisted reproductive treatment cycle involving embryo thawing (for endometriosis-only cases)
- Confirmed diagnosis of adenomyosis only with no ultrasound evidence of endometriosis and enrolled in an assisted reproductive treatment cycle involving embryo thawing (for adenomyosis-only cases)
- Undergone ultrasound screening excluding endometriosis or adenomyosis and listed for assisted reproductive treatment within their first or second IVF cycle with reduced ovarian reserve or non-severe male factor infertility (for control group)
You will not qualify if you...
- Unable or unwilling to sign the informed consent
- Presence of sactosalpinx or other uterine pathologies such as fibroids, polyps, or irregular endometrial thickening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Azienda Ospedaliero Universitaria Renato Dulbecco di Catanzaro
Catanzaro, Catanzaro, Italy, 88100
Active, Not Recruiting
2
IRCCS San Raffaele Hospital
Milan, Milano, Italy, 20132
Actively Recruiting
Research Team
L
LUCA PAGLIARDINI
CONTACT
E
ENRICO PAPALEO
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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