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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Universitario Doctor José Molina Orosa
NOT_YET_RECRUITING
Arrecife
Hospital Universitario Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Burgos
NOT_YET_RECRUITING
Burgos
Hospital Universitario de Cabueñes
NOT_YET_RECRUITING
Gijón
Hospital General de Granollers
NOT_YET_RECRUITING
Granollers
Consorci Sanitari de l'Anoia
NOT_YET_RECRUITING
Igualada
Hospital Universitario de Jaén
NOT_YET_RECRUITING
Jaén
Consorci Sanitari Integral
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario San Pedro
NOT_YET_RECRUITING
Logroño
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Central de Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Universitario Son Espases
NOT_YET_RECRUITING
Palma De Mallorca
Consorci Corporació Sanitària Parc Taulí
NOT_YET_RECRUITING
Sabadell
Hospital General Universitario Los Arcos del Mar Menor
NOT_YET_RECRUITING
San Javier
Parc Sanitari Sant Joan de Deu
NOT_YET_RECRUITING
Sant Boi De Llobregat
Hospital Universitari General de Catalunya
NOT_YET_RECRUITING
Sant Cugat Del Vallès
Hospital Universitario Joan XXIII
NOT_YET_RECRUITING
Tarragona
Hospital Recoletas Salud Campo Grande
NOT_YET_RECRUITING
Valladolid
Hospital de Viladecans
NOT_YET_RECRUITING
Viladecans
Hospital Universitario de Álava - Txagorritxu
NOT_YET_RECRUITING
Vitoria-gasteiz
Hospital Clínico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Amparo Garcia-Tejedor, MDPhD
agarciat@bellvitgehospital.cat
34 + 932607695
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 288
Treatments
Experimental: Ultrasound-guided aspiration and alcohol sclerotherapy
US-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.
No_intervention: Control group
Expectant management with standard pain management if required
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari de Bellvitge
Collaborators: Carlos III Health Institute

This content was sourced from clinicaltrials.gov