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

Sponsor: Hospital Universitari de Bellvitge • ClinicalTrials.gov ID: NCT06955221

Registry updated: 2026-10-19

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Description

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.

Interventions

Ultrasound-guided aspiration and alcohol sclerotherapy (Procedure)
Ultrasound-guided puncture and alcohol sclerotherapy

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

Conditions

Endometrioma Ultrasound Therapy; Complications Quality of Life Pelvic Pain

Locations

Hospital Universitario Son Espases — Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Germans Trias i Pujol — Badalona, Barcelona, Spain
Consorci Sanitari de l'Anoia — Igualada, Barcelona, Spain
Consorci Sanitari Integral — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital San Juan de Dios de Martorell — Martorell, Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí — Sabadell, Barcelona, Spain
Parc Sanitari Sant Joan de Deu — Sant Boi de Llobregat, Barcelona, Spain
Hospital de Viladecans — Viladecans, Barcelona, Spain
Hospital Universitario San Pedro — Logroño, La Rioja, Spain
Hospital de la Vega Lorenzo Guirao — Cieza, Murcia, Spain
Hospital General Universitario Los Arcos del Mar Menor — San Javier, Murcia, Spain
Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitari Sant Joan de Reus — Reus, Tarragona, Spain
Hospital del Mar — Barcelona, Spain
Hospital Universitario de Burgos — Burgos, Spain
Clínica Sanabria — Granada, Spain
Hospital Universitario de Jaén — Jaén, Spain
Hospital Universitario Arnau de Vilanova — Lleida, Spain
Hospital Universitario Ramón y Cajal — Madrid, Spain
Hospital Clínico San Carlos — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitario Joan XXIII — Tarragona, Spain
Consorcio Hospital General Universitario de València — Valencia, Spain
Hospital Recoletas Salud Campo Grande — Valladolid, Spain
Hospital Clínico Universitario Lozano Blesa — Zaragoza, Spain
Hospital Universitario de Álava - Txagorritxu — Vitoria-Gasteiz, Álava, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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