Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
ESCOMA
Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life
1 other identifier
interventional
288
1 country
28
Brief 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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 23, 2026
April 1, 2026
2 years
April 8, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life of patients with endometrioma
Endometriosis Health Profile-5 (EHP-5), the minimum and maximum values (1-5), higher scores mean a worse outcome.
Baseline and at 6 months
Secondary Outcomes (4)
Pelvic pain
Baseline and at 6 months
Fertility preservation
Baseline and at 6 months
Antral follicle
Baseline and at 6 months
Pregnacy
through study completion, an average of 2 year
Study Arms (2)
Ultrasound-guided aspiration and alcohol sclerotherapy
EXPERIMENTALUS-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.
Control group
NO INTERVENTIONExpectant management with standard pain management if required
Interventions
Ultrasound-guided puncture and alcohol sclerotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari de Bellvitgelead
- Carlos III Health Institutecollaborator
Study Sites (28)
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07210, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital General de Granollers
Granollers, Barcelona, 08042, Spain
Consorci Sanitari de l'Anoia
Igualada, Barcelona, 08700, Spain
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208, Spain
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, 08830, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital de Viladecans
Viladecans, Barcelona, 08840, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Canary Islands, 35500, Spain
Hospital Universitario San Pedro
Logroño, La Rioja, 26006, Spain
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, 30739, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Clínica Sanabria
Granada, 18012, Spain
Hospital Universitario de Jaén
Jaén, 23007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitario Joan XXIII
Tarragona, 43005, Spain
Hospital Recoletas Salud Campo Grande
Valladolid, 47007, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Álava, 01009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amparo Garcia-Tejedor, MDPhD
Hospital Universitario de Bellvitge
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking Description
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor, Principal Investigator
Study Record Dates
First Submitted
April 8, 2025
First Posted
May 2, 2025
Study Start
January 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share