Global transcriptomic changes occur in uterine fluid-derived extracellular vesicles during the endometrial window for embryo implantation.
E Giacomini, G M Scotti, V S Vanni...
https://pubmed.ncbi.nlm.nih.gov/34190319Actively Recruiting
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID06572852
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
26 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
Researchers are studying chronic gynecological conditions called endometriosis and adenomyosis, which affect women's reproductive health. This observational, multicenter study aims to improve early diagnosis and personalized treatment using a multi-omic approach. This includes integrating genetic, epigenetic, imaging, and endometrial receptivity data, with the goal of refining image-based predictions through artificial intelligence and examining uterine extracellular vesicles to assess fertility without invasive methods. The study involves four groups of women: those diagnosed with both endometriosis and adenomyosis, those with only endometriosis, those with only adenomyosis, and a control group of infertile women without these conditions. Blood samples for genetic and epigenetic analysis, ultrasound images for machine learning, and uterine fluid samples for gene expression studies are collected. Additionally, retrospective biobank samples from women with endometriosis are used for genetic comparison. Participants will undergo ultrasound screenings, provide blood and uterine fluid samples, and complete clinical questionnaires. Researchers will analyze epigenetic and genetic profiles, develop diagnostic models combining ultrasound and molecular data, and study gene expression from uterine fluid extracellular vesicles at specific menstrual cycle times. The study duration is planned for 24 months from recruitment start to data analysis, aiming to enhance diagnosis and understanding of these conditions' impact on fertility.
CONDITIONS
Brief Title
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis
Who Can Participate
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Able to give informed consent for participation in the study
- European descent
- Confirmed diagnosis of both endometriosis and adenomyosis through ultrasound screening (for the combined diagnosis group)
- Listed for assisted reproductive treatment, specifically within their first or second IVF cycle
- Confirmed diagnosis of endometriosis with no ultrasound evidence of adenomyosis (for endometriosis only group)
- Enrolled in an assisted reproductive treatment cycle involving embryo thawing (for endometriosis only group)
- Confirmed diagnosis of adenomyosis with no ultrasound evidence of endometriosis (for adenomyosis only group)
- Enrolled in an assisted reproductive treatment cycle involving embryo thawing (for adenomyosis only group)
- Undergone ultrasound screenings that excluded endometriosis or adenomyosis (for control group)
- Presence of 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
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for ultrasound screening and eligibility assessment
Diagnostic Evaluation
Duration - Up to 24 months from recruitment to final analysis
Participants undergo blood collection for genetic and epigenetic analysis, ultrasound imaging for machine learning analysis, and in some cases, uterine fluid collection for gene expression profiling through uterine fluid extracellular vesicles (UF-EVs).
1 to 2 visits depending on group assignment
Long-term Monitoring
Duration - Up to 24 months
Participants' diagnostic data is analyzed over time to develop and validate diagnostic models integrating genetic, epigenetic, ultrasound imaging, and clinical data.
No additional visits; analysis conducted on collected data
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
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Research Team
L
LUCA PAGLIARDINI
E
ENRICO PAPALEO
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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Published Research Related To This Trial
Association of endometriosis and adenomyosis with pregnancy and infertility.
Paolo Vercellini, Paola Viganò, Veronica Bandini...
https://pubmed.ncbi.nlm.nih.gov/36948440