Clinical Trial

Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis

Study acronym: ESCOMA
Recruiting
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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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2025-04-30; most recent amendment 2026-07-24.
Status change: Not Yet Recruiting → Recruiting 2025-06-17
Trial Details
NCT Number NCT06955221
Lead Sponsor Hospital Universitari de Bellvitge
Collaborators: Carlos III Health Institute
Conditions Endometrioma, Ultrasound Therapy; Complications, Quality of Life, Pelvic Pain
Enrollment 288 participants
Start Date 2025-01-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27