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

May 7, 2026 updated by: Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic gynecological disease that affects women of reproductive age, characterized by the abnormal growth of endometrial tissue outside the uterine cavity.

It affects 5-10% of women of reproductive age (Becker et al., 2022) and is associated with infertility in 40% of cases (Coccia et al., 2008). Among its clinical forms, ovarian endometrioma is the most frequent, appearing in 15-45% of patients with endometriosis (Cranney et al., 2017). In addition to its impact on fertility, the main clinical manifestation of endometriosis is pain. Chronic pelvic pain caused by endometriosis can be disabling and even lead to work absenteeism, with a significant impact on the quality of life of affected patients, who often experience delayed diagnosis, making its management even more difficult and requiring a multidisciplinary approach (Horne & Missmer, 2022).

Currently, there is still no consensus on what should be the first-line treatment for ovarian endometrioma (Gordts & Campo, 2019). However, cystectomy reduces ovarian reserve due to the removal of healthy ovarian tissue adjacent to the cyst wall-something that further worsens the reproductive prognosis in patients whose fertility is already diminished due to endometriosis per se (Alborzi et al., 2021; Martinez-Garcia et al., 2021). Moreover, despite surgical removal of the endometrioma, the recurrence rate is high, ranging from 15-30% (Jee, 2022).

In recent years, there has been a shift toward more conservative treatments for the management of endometrioma, such as expectant management or aspiration and sclerosis (Garcia-Tejedor et al., 2020). Various authors have shown that ultrasound-guided aspiration and alcohol sclerosis may be a promising option, as concluded in the meta-analysis by Cohen et al., which found that recurrence rates were similar to those of laparoscopic management of ovarian endometrioma, but with fewer complications. Results in assisted reproductive technology are also better compared to surgical treatment in symptomatic women, particularly in those with low ovarian reserve (Zhang et al., 2022). Furthermore, other comparative studies between surgery and aspiration-sclerosis have shown that, although recurrence rates are similar, pregnancy rates are higher in patients treated with sclerosis, with the same complication rate and significantly lower costs (Garcia-Tejedor et al., 2020; Zhang et al., 2022).

Currently, the first-line treatment in patients diagnosed with endometriosis is hormonal therapy through the use of hormonal contraceptives. However, its efficacy in managing endometrioma is lower, and therefore, there is no consensus on its indication for this specific form of endometriosis (Cranney et al., 2017). In patients with a desire for pregnancy, alternative approaches are sought that do not interfere with fertility. At present, this often involves proceeding with in vitro fertilization without treating the endometrioma first, followed by surgery if needed (Miquel et al., 2020).

In addition to reproductive outcomes in patients affected by endometriosis, symptomatology and its consequent impact on quality of life have become highly relevant factors in treatment selection. Accordingly, specific pain scales and quality-of-life questionnaires have been developed to assess the impact on women affected by this condition. One such tool is the Endometriosis Health Profile scale, available in two versions (EHP-30 and EHP-5), designed by Dr. Stephen Kennedy and his team at the University of Oxford. It is a validated scale for assessing quality of life in patients with endometriosis and has been translated into nearly all languages (Jones et al., 2023; Bourdel et al., 2019).

The main objective of this project is to conduct a comparative analysis of patients diagnosed with ovarian endometrioma who undergo alcohol aspiration and sclerosis versus patients managed expectantly.

The outcomes to be evaluated include impact on quality of life, clinical improvement, pregnancy rate, and the need for subsequent surgery.

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital Del Mar
        • Contact:
        • Principal Investigator:
          • Mauricio Agüero
      • Burgos, Spain, 09006
        • Not yet recruiting
        • Hospital Universitario de Burgos
        • Contact:
        • Principal Investigator:
          • Modesto Rey Novoa
      • Granada, Spain, 18012
        • Not yet recruiting
        • Clínica Sanabria
        • Contact:
        • Principal Investigator:
          • Macarena Ríos Lorenzo
      • Jaén, Spain, 23007
        • Not yet recruiting
        • Hospital Universitario de Jaén
        • Contact:
        • Principal Investigator:
          • Antonio Carballo García
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • Irene Pelayo Delgado
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Ignacio Cristóbal Quevedo
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 De Octubre
        • Contact:
        • Principal Investigator:
          • Gregorio López González
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Lola Lara Domínguez
      • Tarragona, Spain, 43005
        • Not yet recruiting
        • Hospital Universitario Joan XXIII
        • Contact:
        • Principal Investigator:
          • María Gómez Romero
      • Valladolid, Spain, 47007
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
        • Principal Investigator:
          • Ana Cristina Lou
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07210
        • Not yet recruiting
        • Hospital Universitario Son Espases
        • Contact:
        • Principal Investigator:
          • Ana Belén Castel Segui
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Not yet recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Sara Iglesias
      • Granollers, Barcelona, Spain, 08042
        • Not yet recruiting
        • Hospital General De Granollers
        • Contact:
        • Principal Investigator:
          • Nuria Sarasa
      • Igualada, Barcelona, Spain, 08700
        • Not yet recruiting
        • Consorci Sanitari de l'Anoia
        • Contact:
        • Principal Investigator:
          • Jennifer Rovira
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Amparo Garcia-Tejedor
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Recruiting
        • Consorci Sanitari Integral
        • Contact:
        • Principal Investigator:
          • Marta Castellarnau
      • Sabadell, Barcelona, Spain, 08208
        • Not yet recruiting
        • Consorci Corporacio Sanitaria Parc Tauli
        • Contact:
        • Principal Investigator:
          • Laura Costa
      • Sant Boi de Llobregat, Barcelona, Spain, 08830
        • Not yet recruiting
        • Parc Sanitari Sant Joan de Deu
        • Contact:
        • Principal Investigator:
          • Manel Carreras
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Not yet recruiting
        • Hospital Universitari General de Catalunya
        • Contact:
        • Principal Investigator:
          • Margarita Gomez del Valle
      • Viladecans, Barcelona, Spain, 08840
        • Recruiting
        • Hospital de Viladecans
        • Principal Investigator:
          • Cristina Molinet
        • Contact:
    • Canary Islands
      • Arrecife, Canary Islands, Spain, 35500
        • Not yet recruiting
        • Hospital Universitario Doctor José Molina Orosa
        • Contact:
        • Principal Investigator:
          • Marta Bazan Legasa
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Not yet recruiting
        • Hospital Universitario San Pedro
        • Contact:
        • Principal Investigator:
          • Maria Victoria Corbalán
    • Murcia
      • San Javier, Murcia, Spain, 30739
        • Not yet recruiting
        • Hospital General Universitario Los Arcos del Mar Menor
        • Contact:
        • Principal Investigator:
          • Shiana Corbalán
    • Principality of Asturias
      • Gijón, Principality of Asturias, Spain, 33394
        • Not yet recruiting
        • Hospital Universitario de Cabueñes
        • Contact:
        • Principal Investigator:
          • Elena López Viesca
      • Oviedo, Principality of Asturias, Spain, 33011
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • María José Rodríguez
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Not yet recruiting
        • Hospital Universitario de Canarias
        • Contact:
        • Principal Investigator:
          • Ana Isabel Padilla Pérez
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Not yet recruiting
        • Hospital Universitari Sant Joan de Reus
        • Contact:
        • Principal Investigator:
          • Rosa Pedro Carulla
    • Álava
      • Vitoria-Gasteiz, Álava, Spain, 01009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided aspiration and alcohol sclerotherapy
US-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.
Procedure: Ultrasound-guided aspiration and alcohol sclerotherapy
Ultrasound-guided puncture and alcohol sclerotherapy
No Intervention: Control group
Expectant management with standard pain management if required

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life of patients with endometrioma
Time Frame: Baseline and at 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic pain
Time Frame: Baseline and at 6 months
Visual Analog Score for pain (dysmenorrhea), the minimum and maximum values (0-10), higher scores mean a worse outcome.
Baseline and at 6 months
Fertility preservation
Time Frame: Baseline and at 6 months
Blood test: Antimullerian Hormone
Baseline and at 6 months
Antral follicle
Time Frame: Baseline and at 6 months
Antral follicle count by US
Baseline and at 6 months
Pregnacy
Time Frame: through study completion, an average of 2 year
Number of spontaneous pregnancies or pregnancies achieved through assisted reproductive techniques
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Carlos III Health Institute

Investigators

  • Principal Investigator: Amparo Garcia-Tejedor, MDPhD, Hospital Universitario de Bellvitge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR 070/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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