Alcohol sclerotherapy for pelvic pain and quality of life in ovarian endometrioma
Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life
This trial will try ultrasound-guided alcohol sclerotherapy to see if it reduces pelvic pain and improves quality of life in women aged 18–45 with ovarian endometriomas compared with expectant management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 29 sites (Palma de Mallorca, Balearic Islands and 28 other locations) |
| Trial ID | NCT06955221 on ClinicalTrials.gov |
What this trial studies
Women meeting entry criteria are randomly assigned to receive ultrasound-guided aspiration with alcohol sclerotherapy or to expectant management, with outcomes compared at six months. Pain and quality of life are measured using standardized instruments including the EHP-5, and blood and urine samples are collected for biomarkers such as cortisol, IL-6, and hsCRP. The intervention is a minimally invasive outpatient procedure performed under ultrasound guidance, and the control arm receives routine monitoring without immediate intervention. The trial focuses on unilocular or thin-septum endometriomas sized 30–100 mm and excludes cases with suspicion of malignancy or indications for immediate surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18–45 with ultrasound-suspected unilocular (or thin-septum) ovarian endometriomas 30–100 mm in size, CA125 ≤300 UI/mL and HE4 ≤70 pM, not pregnant and willing to give informed consent.
Not a fit: Patients with very small (<30 mm) or very large (>100 mm) cysts, ultrasound signs suggesting dermoid or high malignancy risk, those requiring surgical treatment for severe extra-ovarian disease, pregnant women, or those with prior ovarian/uterine cancer are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the procedure could reduce pelvic pain and improve quality of life while avoiding or delaying surgery and preserving ovarian tissue.
How similar studies have performed: Smaller series and nonrandomized reports have shown symptom relief and cyst reduction after alcohol sclerotherapy, but high-quality randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palma de Mallorca, Balearic Islands and 28 other locations
- 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)
- Hospital General de Granollers — Granollers, 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)
- 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 General Universitario Los Arcos del Mar Menor — San Javier, Murcia, Spain (Not_yet_recruiting)
- Hospital Universitario de Cabueñes — Gijón, Principality of Asturias, Spain (Not_yet_recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Not_yet_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 Ramón y Cajal — Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (Not_yet_recruiting)
- Hospital Universitario Joan XXIII — Tarragona, 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)
Study contacts
- Principal investigator: Amparo Garcia-Tejedor, MDPhD — Hospital Universitario de Bellvitge
- Study coordinator: Amparo Garcia-Tejedor, MDPhD
- Email: agarciat@bellvitgehospital.cat
- Phone: 34 + 932607695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.