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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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 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.