RecruitingNot ApplicableNCT06955221

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

Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life


Sponsor

Hospital Universitari de Bellvitge

Enrollment

288 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Ultrasound-guided aspiration and alcohol sclerotherapy for people with endometrioma, pelvic pain, and other related conditions. The study is currently recruiting participants at 29 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUltrasound-guided aspiration and alcohol sclerotherapy

Ultrasound-guided puncture and alcohol sclerotherapy


Locations(28)

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

Hospital San Juan de Dios de Martorell

Martorell, 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 de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario de Burgos

Burgos, Spain

Clínica Sanabria

Granada, 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 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

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NCT06955221


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