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
- Diseases
- Endometriosis
- 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
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Not yet recruiting |
| Hospital de la Vega Lorenzo Guirao Coordinator of this site? Confirm its status | Cieza | Spain | Not yet recruiting |
| Clínica Sanabria Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Consorci Sanitari de l'Anoia Coordinator of this site? Confirm its status | Igualada | Spain | Recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Not yet recruiting |
| Consorci Sanitari Integral Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Not yet recruiting |
| Hospital Universitario San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital San Juan de Dios de Martorell Coordinator of this site? Confirm its status | Martorell | Spain | Not yet recruiting |
| Hospital Universitario Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Not yet recruiting |
| Hospital Universitari Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Not yet recruiting |
| Consorci Corporació Sanitària Parc Taulí Coordinator of this site? Confirm its status | Sabadell | Spain | Not yet recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | San Cristóbal de La Laguna | Spain | Not yet recruiting |
| Hospital General Universitario Los Arcos del Mar Menor Coordinator of this site? Confirm its status | San Javier | Spain | Recruiting |
| Parc Sanitari Sant Joan de Déu Coordinator of this site? Confirm its status | Sant Boi de Llobregat | Spain | Not yet recruiting |
| Hospital Universitario Joan XXIII Coordinator of this site? Confirm its status | Tarragona | Spain | Not yet recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Recoletas Salud Campo Grande Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Hospital de Viladecans Coordinator of this site? Confirm its status | Viladecans | Spain | Recruiting |
| Hospital Universitario de Álava - Txagorritxu Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.