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NCT07282990Not yet recruiting

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

Evolution of Endometriosis Lesions and Quality of Life of Patients

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
1 Dec 2025
Start date
1 Dec 2025
Primary completion date
31 May 2028
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
NCT number
NCT07282990

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Dec 2025 to the primary completion date, 31 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with an indication for scheduled surgical treatment within the next two years. This includes patients requiring surgery for the removal of endometriotic lesions or to address related complications.
  • Patients who are unwilling to participate in the study after receiving all the information and providing their informed consent. Voluntary participation is crucial for the ethics of the study.
  • Patients with serious concurrent illnesses or medical conditions that may interfere with the assessment of endometriosis, its progression, or the impact of treatment (e.g., severe chronic inflammatory diseases or cancer).
  • Patients receiving concurrent treatments not permitted by the study protocol (e.g., experimental treatments for endometriosis or related conditions) that may interfere with the interpretation of the results.

Other illness

  • Patients who are unwilling to undergo follow-up transvaginal ultrasound at scheduled visits (6 months, 1 year, 2 years). Ultrasound is essential for assessing disease progression and the impact of treatment.
  • Patients with intellectual disabilities or conditions that impair their understanding of the study terms and procedures, which could affect their ability to provide valid informed consent.
  • Patients who are pregnant or breastfeeding at the time of enrollment. These conditions can influence the course of endometriosis and the response to treatment, and could complicate disease monitoring.

Who the study is looking for

  • Women with a confirmed diagnosis of endometriosis, based on ultrasound criteria. Diagnosis must be confirmed by transvaginal ultrasound with evidence of visible and measurable endometriotic lesions.
  • Patients over 18 years of age. This criterion ensures that participants can provide informed consent and are of reproductive age, when the effects of endometriosis and its treatments are relevant to the study.
  • A transvaginal ultrasound performed prior to enrollment showing endometriotic lesions (either endometriomas or deep lesions) with sufficient dimensions and characteristics for evaluation and follow-up.
  • Patients who do not have an indication for scheduled surgery within the next two years. This ensures that the effects of treatment and the progression of the disease can be evaluated throughout the study follow-up period.
  • Signed informed consent from the patient, indicating that she has understood the purpose of the study, the procedures involved, and the potential risks.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.