Evolution of Endometriosis Lesions Followed by Ultrasound and Quality of Life of Patients: Factor… (NCT07282990) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evolution of Endometriosis Lesions Followed by Ultrasound and Quality of Life of Patients: Factors That Influence Disease Progression in a Prospective Cohort
Spain100 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Ultrasound-assessed progression of endometriosic lesions at recruitment, 6, 12 and 24 months
Timeframe: From enrollment to the end of follow-up at 24 months
2
Evolution of clinical presentation at recruitment, 6, 12 and 24 months
Timeframe: From enrollment to the end of follow-up at 24 months
Trial details
NCT IDNCT07282990
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
✕. 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 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 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.
✕. 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.