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NCT06955221Recruiting

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
288 (estimated)
First submitted
8 Apr 2025
Start date
1 Jan 2025
Primary completion date
31 Dec 2026
Lead sponsor
Hospital Universitari de Bellvitge
NCT number
NCT06955221

What you commit to

  • Study type: Interventional
  • Planned participants: 288
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2026
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Indication for surgical treatment of the endometrioma due to suspected severe extra-ovarian endometriosis or any other cause

Other illness

  • History of ovarian or uterine cancer
  • Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy

Age

  • Age \<18 or \>45 years

Other

  • Endometrioma size \<30 mm or \>100 mm
  • Ca125 \>300 UI/mL
  • HE4 \>70 pM
  • Pregnant women
  • Patients who do not wish to participate in the study or who are mentally incapacitated

Who the study is looking for

  • 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

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario De Burgos
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BurgosSpainNot yet recruiting
Hospital de la Vega Lorenzo Guirao
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CiezaSpainNot yet recruiting
Clínica Sanabria
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GranadaSpainNot yet recruiting
Consorci Sanitari de l'Anoia
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IgualadaSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainNot yet recruiting
Consorci Sanitari Integral
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L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario de Bellvitge
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Arnau de Vilanova
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LleidaSpainNot yet recruiting
Hospital Universitario San Pedro
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LogroñoSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital San Juan de Dios de Martorell
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MartorellSpainNot yet recruiting
Hospital Universitario Son Espases
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Palma de MallorcaSpainNot yet recruiting
Hospital Universitari Sant Joan de Reus
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ReusSpainNot yet recruiting
Consorci Corporació Sanitària Parc Taulí
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SabadellSpainNot yet recruiting
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainNot yet recruiting
Hospital General Universitario Los Arcos del Mar Menor
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San JavierSpainRecruiting
Parc Sanitari Sant Joan de Déu
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Sant Boi de LlobregatSpainNot yet recruiting
Hospital Universitario Joan XXIII
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TarragonaSpainNot yet recruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainNot yet recruiting
Hospital Recoletas Salud Campo Grande
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ValladolidSpainRecruiting
Hospital de Viladecans
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ViladecansSpainRecruiting
Hospital Universitario de Álava - Txagorritxu
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Vitoria-GasteizSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.