EndometrioSis PRediction and Assessment of InflammaTion

Completed

• Conditions: Endometriosis

• Registration Number: NCT07114081
• Lead Sponsor: Imperial College London

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2024-02-01
• Status Verified: 2025-08
• Study Completion: 2025-08-01
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 264

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endometriosis predictive model	24 months	Multiple logistic regression model of predictive variables

Secondary Outcome Measures

Name	Time	Method
Markers of inflammation	24 months	Cytokine multiplex for markers of inflammation in peripheral blood

Trial Locations

Locations (1)

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom