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OpenTrials
Completed

NCT Number: NCT07114081

EndometrioSis PRediction and Assessment of InflammaTion

The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis.

The main questions it aims to answer are:

Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?

Completed

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.

Exclusion criteria

  • previous surgically confirmed endometriosis;
  • postmenopausal status;
  • laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
  • suspicion of malignancy;
  • the sole indication of tubal sterilisation;
  • the sole indication of myomectomy;
  • pregnant or breastfeeding;
  • significant medical co-morbidities including HIV and/or hepatitis B or C infection;
  • where gynaecology is not the primary team undertaking surgery;
  • unable to have transvaginal ultrasound (TVUSS);
  • declines to take part in the study;
  • patient unable to understand verbal or written information in English;
  • lack of capacity to consent at the point of recruitment;
  • known safeguarding issues.

Treatment and study plan

Diagnostic laparoscopy

Diagnostic Test

Minimal access surgery to determine the presence of characteristic endometriosis lesions on visual inspection of the pelvis

Primary outcomes

  1. Endometriosis predictive model

    Time frame: 24 months

    Multiple logistic regression model of predictive variables

Secondary outcomes

  1. Markers of inflammation

    Time frame: 24 months

    Cytokine multiplex for markers of inflammation in peripheral blood

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Exploring Pre-operative Prediction of Pelvic Endometriosis, the Local Inflammatory Environment and Response to Surgical Treatment

Acronym: ESPRIT

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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