Evolution of Endometriosis Lesions Followed by Ultrasound and Quality of Life of Patients: Factors That Influence Disease Progression in a Prospective Cohort

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study ID
NCT07282990
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this prospective cohort study is to determine the factors that influence the progression of endometriosis and the quality of life of patients. The main questions it aims to answer are: 1. Is endometriosis a progressive disease? 2. Is the progression of lesions visualized by ultrasound dependent on the medical treatment received? 3. Does the clinical progression of patients correlate with the progression of lesions visualized on transvaginal ultrasound? 4. Is ultrasound follow-up necessary for patients? 5. Could clinical follow-up alone be safe for selected patients? Researchers will follow up a prospective cohort of 100 patients diagnosed with deep infiltrating endometriosis (DIE) +/- endometriomas during 2 years, collecting data regarding their ultrasound exam and their symptoms and quality of life at stablished controls at recruitment, 6 months, 12 months and 24 months.

Key Dates

First listed
Dec 15, 2025
Start date
Dec 31, 2025
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Women diagnosed with endometriosis, referred for treatment and/or follow-up to Reference Unit
    The study population consists of adult women (18 years or older) with a confirmed diagnosis of endometriosis based on transvaginal ultrasound showing clearly visible and measurable lesions (endometriomas or deep endometriotic lesions suitable for evaluation and follow-up), who are referred for a first consultation at the Endometriosis Reference Unit in Hospital Sant Pau. Patients must not have an expected indication for surgical intervention within the next two years, ensuring stable monitoring of disease progression and treatment effects.

Primary Outcome Measure

Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months [ Time Frame: From enrollment to the end of follow-up at 24 months ]

Central Contacts

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