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EndometriomaESCOMANCT06955221

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

A study testing Ultrasound-guided aspiration and alcohol sclerotherapy in people with Endometrioma and Ultrasound Therapy; Complications, run by Hospital Universitari de Bellvitge at 27 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Ultrasound-guided aspiration and alcohol sclerotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
27 sitesSpain
Study dates
1 Jan 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • HE4 >70 pM
  • Pregnant women
  • Patients who do not wish to participate in the study or who are mentally incapacitated

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amparo Garcia-Tejedor, MDPhD contact

34 + 932607695 ext. 2812

agarciat@bellvitgehospital.cat

27 sites in 1 country

Spain27 sites, 27 recruiting
  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Sara Iglesias, siglesiasf.mn.ics@gencat.cat

    Sara Iglesias

    Not yet recruiting
  • Hospital del Mar

    Barcelona, 08003

    Mauricio Agüero, maguero@psmar.cat

    Mauricio Agüero

    Recruiting
  • Hospital Universitario de Burgos

    Burgos, 09006

    Irene Gonzalo García, igonzalo@saludcastillayleon.es

    Irene Gonzalo García

    Not yet recruiting
  • Hospital de la Vega Lorenzo Guirao

    Cieza, Murcia, 30530

    Esperanza Gadea Niñoles, egn-75@hotmail.com

    Esperanza Gadea Niñoles

    Not yet recruiting
  • Clínica Sanabria

    Granada, 18012

    Macarena Ríos Lorenzo, macarenarios21@gmail.com

    Macarena Ríos Lorenzo

    Not yet recruiting
  • Consorci Sanitari de l'Anoia

    Igualada, Barcelona, 08700

    Jennifer Rovira, jrovira@csa.cat

    Jennifer Rovira

    Recruiting
  • Hospital Universitario de Jaén

    Jaén, 23007

    Antonio Carballo García, antonio.gine@gmail.com

    Antonio Carballo García

    Not yet recruiting
  • Consorci Sanitari Integral

    L'Hospitalet de Llobregat, Barcelona, 08906

    Marta Castellarnau, yembe10@yahoo.es

    Marta Castellarnau

    Recruiting
  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Amparo Garcia-Tejedor, agarciat@bellvitgehospital.cat

    Amparo Garcia-Tejedor

    Recruiting
  • Hospital Universitario Arnau de Vilanova

    Lleida, 25198

    Núria Muñiz López, nmuniz.lleida.ics@gencat.cat

    Núria Muñiz López

    Not yet recruiting
  • Hospital Universitario San Pedro

    Logroño, La Rioja, 26006

    María Carmen Salvador Ballada, csalvador@riojasalud.es

    María Carmen Salvador Ballada

    Not yet recruiting
  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Irene Pelayo Delgado, irene.pelayo@salud.madrid.org

    Irene Pelayo Delgado

    Recruiting
  • Hospital Clínico San Carlos

    Madrid, 28040

    Ignacio Cristóbal Quevedo, icristobal@salud.madrid.org

    Ignacio Cristóbal Quevedo

    Recruiting
  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Gregorio López González, goyolopez2@hotmail.com

    Gregorio López González

    Recruiting
  • Hospital San Juan de Dios de Martorell

    Martorell, Barcelona, 08760

    Ángel Toro, atoro@hmartorell.cat

    Ángel Toro

    Not yet recruiting
  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07210

    Ana Belén Castel Segui, anab.castel@ssib.es

    Ana Belén Castel Segui

    Not yet recruiting
  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

    Rosa Pedro Carulla, rosa.pedro.carulla@gmail.com

    Rosa Pedro Carulla

    Not yet recruiting
  • Consorci Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

    Laura Costa, LCOSTA@tauli.cat

    Laura Costa

    Not yet recruiting
  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

    Ana Isabel Padilla Pérez, apadillp@ull.edu.es

    Ana Isabel Padilla Pérez

    Not yet recruiting
  • Hospital General Universitario Los Arcos del Mar Menor

    San Javier, Murcia, 30739

    Shiana Corbalán, shiana.corbalan@gmail.com

    Shiana Corbalán

    Recruiting
  • Parc Sanitari Sant Joan de Deu

    Sant Boi de Llobregat, Barcelona, 08830

    Manel Carreras, manuel.carreras@sjd.es

    Manel Carreras

    Not yet recruiting
  • Hospital Universitario Joan XXIII

    Tarragona, 43005

    María Gómez Romero, mariagomez8@gmail.com

    María Gómez Romero

    Not yet recruiting
  • Consorcio Hospital General Universitario de València

    Valencia, 46014

    Susana Royo, draroyo.s@gmail.com

    Susana Royo

    Not yet recruiting
  • Hospital Recoletas Salud Campo Grande

    Valladolid, 47007

    Isabel Gippini, isabel.gippini@gruporecoletas.com

    Isabel Gippini

    Recruiting
  • Hospital de Viladecans

    Viladecans, Barcelona, 08840

    Cristina Molinet, cmolinet.hv@gencat.cat

    Cristina Molinet

    Recruiting
  • Hospital Universitario de Álava - Txagorritxu

    Vitoria-Gasteiz, Álava, 01009

    Janire González, janire.gonzalezcalvino@osakidetza.eus

    Janire González

    Not yet recruiting
  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

    Ana Cristina Lou, dra.aclou@gmail.com

    Ana Cristina Lou

    Not yet recruiting

Other trials in Spain

About this study

Official title: 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:

Read more
  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.

Read the 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.

Being tested
Ultrasound-guided aspiration and alcohol sclerotherapy
Medical subject headings
Endometriosis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided aspiration and alcohol sclerotherapyProcedure or surgery

    Ultrasound-guided puncture and alcohol sclerotherapy

Study groups in NCT06955221
Study groupRoleWhat they receive
Ultrasound-guided aspiration and alcohol sclerotherapyExperimentalUS-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.
Receives: Procedure: Ultrasound-guided aspiration and alcohol sclerotherapy
Control groupNo interventionExpectant management with standard pain management if required

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and at 6 months

Secondary outcomes (14)
  1. Pelvic pain

    Visual Analog Score for pain (dysmenorrhea), the minimum and maximum values (0-10), higher scores mean a worse outcome.

    Measured: Baseline and at 6 months

  2. Changes in pain-associated biomarkers 1

    Blood: cortisol

    Measured: Baseline and at 6 months

  3. Changes in pain-associated biomarkers 2

    Blood: CRP

    Measured: Baseline and at 6 months

  4. Changes in pain-associated biomarkers 3

    Blood: IL-6

    Measured: Baseline and at 6 months

  5. Changes in pain-associated biomarkers 4

    Urine: cortisol

    Measured: Baseline and at 6 months

  6. Changes in pain-associated biomarkers 5

    Urine: adrenaline

    Measured: Baseline and at 6 months

  7. Changes in pain-associated biomarkers 6

    Urine: noradrenaline

    Measured: Baseline and at 6 months

  8. Fertility preservation

    Blood test: Antimullerian Hormone

    Measured: Baseline and at 6 months

  9. Antral follicle

    Antral follicle count by US

    Measured: Baseline and at 6 months

  10. Pregnancy

    Number of spontaneous pregnancies or pregnancies achieved through assisted reproductive techniques. Time to Conception

    Measured: Through study completion, an average of 2 years

  11. Reduction in cyst size

    Largest diameter

    Measured: Baseline and at 6 months

  12. Adverse events and complications

    Registered by Clavien-Dindo classification

    Measured: Baseline and at 6 months

  13. Misdiagnosed cysts

    Number of patients with alternative diagnosis

    Measured: During procedure

  14. Healthcare costs

    Direct and indirect treatment-related costs; cost-effectiveness analysis

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2025
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Model Description
Masking
None (open label)
Enrolment
288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06955221
Sponsor's protocol ID
PR 070/25
Acronym
ESCOMA
Status last verified
Oct 2026
First submitted
8 Apr 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guevara-Peralta R, Martinez-Garcia JM, Ortega-Exposito C, Pla-Farnos MJ, Yeste C, Penafiel J, Guevara-Figueras J, Ponce J, Garcia-Tejedor A. Impact of ethanol sclerotherapy on pelvic pain and quality of life in patients with endometriomas (ESCOMA study): protocol for a randomised clinical trial. Front Reprod Health. 2026 Sep 10;8:1911200. doi: 10.3389/frph.2026.1911200. eCollection 2026.

    PubMed 42787429

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided aspiration and alcohol sclerotherapy in people with Endometrioma and Ultrasound Therapy; Complications, run by Hospital Universitari de Bellvitge at 27 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amparo Garcia-Tejedor, MDPhD (34 + 932607695 ext. 2812, agarciat@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life of patients with endometrioma (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06955221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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