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Search / Trial NCT06572852

Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis

Launched by IRCCS SAN RAFFAELE · Aug 23, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Case Control Retrospective Prospective Genetic Endometriosis Adenomyosis Machine Learning Epigenetic

ClinConnect Summary

This clinical trial is designed to improve our understanding and diagnosis of endometriosis and adenomyosis, two conditions that can significantly affect women's reproductive health. Researchers are using advanced techniques that combine genetic and imaging data to help diagnose these conditions earlier and create more personalized treatment plans. They are also exploring new ways to assess fertility without invasive procedures by studying tiny particles released from the uterus.

Women who are of European descent and are diagnosed with endometriosis and/or adenomyosis may be eligible to participate, especially if they are seeking fertility treatments like in vitro fertilization (IVF). Participants will provide blood and uterine fluid samples for analysis. The trial is currently recruiting women who meet specific criteria, including those with confirmed diagnoses through ultrasound, and will exclude individuals with certain other uterine conditions. By joining this study, participants can contribute to valuable research that may lead to better diagnosis and treatment options for themselves and others with similar conditions.

Gender

FEMALE

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.

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Milan, Mi, Italy

Catanzaro, , Italy

Milan, Michigan, Italy

Patients applied

0 patients applied

Trial Officials

MASSIMO CANDIANI

Principal Investigator

IRCCS San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported