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CompletedNCT07114081ESPRITUpdated Aug 11, 2025

EndometrioSis PRediction and Assessment of InflammaTion

An observational study in Endometriosis, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
264
Ages
18 Years to 50 Years
Sex
Female
01

Study 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?

02

Conditions studied

  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 264 is above the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Consecutive female patients age 18-50 undergoing gynaecological laparoscopic surgery at included institutions

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
264 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testDiagnostic laparoscopy

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

06

What researchers measure

Primary outcomes

  1. Endometriosis predictive model

    Multiple logistic regression model of predictive variables

    Time frame: 24 months

Secondary outcomes

  1. Markers of inflammation

    Cytokine multiplex for markers of inflammation in peripheral blood

    Time frame: 24 months

07

Study locations

1 site
  • Chelsea and Westminster Hospital NHS Foundation Trust
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — TBC

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07114081
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Jul 1, 2022
Primary completion
Feb 1, 2024
Completion
Aug 1, 2025
Last update
Aug 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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