Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometr… (NCT06955221) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Spain288 participantsStarted 2025-01-01
Plain-language summary
The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management.
The main questions it aims to answer are:
1. \- Does sclerotherapy significantly reduce pelvic pain compared to expectant management?
2. \- Does sclerotherapy improve quality of life as measured by the EHP-5 score?
Researchers will compare the sclerotherapy group to the expectant management group to determine whether the intervention leads to greater improvement in pain and quality of life.
Participants will:
* Be randomly assigned to one of two groups: (1) Sclerotherapy group: undergo ultrasound-guided puncture and alcohol sclerotherapy; (2) Control group: expectant management
* Complete quality of life and pain assessments at baseline and after 6 months
* Provide blood and urine samples for biomarker analysis (e.g., cortisol, IL-6, hsCRP, catecholamines)
* Undergo ovarian reserve assessments (AMH, antral follicle count)
* Be followed for adverse events, recurrence, fertility outcomes, and treatment-related costs
The study will follow an intention-to-treat and per-protocol analysis approach.
Who can participate
Age range
18 Years – 45 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:
* Female sex
* Age ≥18 and ≤45 years
* Ultrasound suspicion of unilocular endometrioma or with a thin septum less than 3 mm
* Size between 30-100 mm, persistent for at least 3-6 months since diagnosis
* Ca125 marker \<300 UI/mL and HE4 \< 70 pM
* Signed informed consent
Exclusion Criteria:
* Age \<18 or \>45 years
* History of ovarian or uterine cancer
* Endometrioma size \<30 mm or \>100 mm
* Indication for surgical treatment of the endometrioma due to suspected severe extra-ovarian endometriosis or any other cause
* Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy
* Ca125 \>300 UI/mL
* HE4 \>70 pM
* Pregnant women
* Patients who do not wish to participate in the study or who are mentally incapacitated
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.