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
- Endometrioma
- Ultrasound Therapy; Complications
- Quality of Life
- Pelvic Pain
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Hospital Universitari de Bellvitge
- Enrolment target
- 288
- Started
- 1 January 2025
- Main results due
- 31 December 2026
- Study sites
- 29
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 45 years.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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 sites(29)
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Not yet recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Not yet recruiting
Consorci Sanitari de l'Anoia
Igualada, Barcelona, Spain
Not yet recruiting
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, Spain
Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Recruiting
Hospital San Juan de Dios de Martorell
Martorell, Barcelona, Spain
Not yet recruiting
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Not yet recruiting
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain
Not yet recruiting
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Not yet recruiting
Hospital de Viladecans
Viladecans, Barcelona, Spain
Recruiting
Hospital Universitario Doctor José Molina Orosa
Arrecife, Canary Islands, Spain
Not yet recruiting
Hospital Universitario San Pedro
Logroño, La Rioja, Spain
Not yet recruiting
Hospital de la Vega Lorenzo Guirao
Cieza, Murcia, Spain
Not yet recruiting
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, Spain
Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Not yet recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Not yet recruiting
Hospital del Mar
Barcelona, Spain
Recruiting
Hospital Universitario de Burgos
Burgos, Spain
Not yet recruiting
Clínica Sanabria
Granada, Spain
Not yet recruiting
Hospital Universitario de Jaén
Jaén, Spain
Not yet recruiting
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid, Spain
Recruiting
Hospital Clínico San Carlos
Madrid, Spain
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Recruiting
Hospital Universitario Joan XXIII
Tarragona, Spain
Not yet recruiting
Consorcio Hospital General Universitario de València
Valencia, Spain
Not yet recruiting
Hospital Recoletas Salud Campo Grande
Valladolid, Spain
Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Not yet recruiting
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Álava, Spain
Not yet recruiting
Showing 29 of 29 sites. 9 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06955221. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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