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Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Sponsor: Hospital Universitari de Bellvitge
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.
Official title: Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2025-01-01
Completion Date
2027-12-31
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
Ultrasound-guided aspiration and alcohol sclerotherapy
Ultrasound-guided puncture and alcohol sclerotherapy
Locations (27)
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital General de Granollers
Granollers, Barcelona, Spain
Consorci Sanitari de l'Anoia
Igualada, Barcelona, Spain
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Hospital de Viladecans
Viladecans, Barcelona, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Canary Islands, Spain
Hospital Universitario San Pedro
Logroño, La Rioja, Spain
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Joan XXIII
Tarragona, Spain
Hospital Recoletas Salud Campo Grande
Valladolid, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Álava, Spain