Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06955221

RecruitingNA

Sponsor: Hospital Universitari de Bellvitge

Conditions: Endometrioma, Ultrasound Therapy; Complications, Quality of Life, Pelvic Pain

Interventions: Ultrasound-guided aspiration and alcohol sclerotherapy

Countries: Spain

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (28)
  • Palma de Mallorca, Balearic Islands, Spain
  • Badalona, Barcelona, Spain
  • Granollers, Barcelona, Spain
  • Igualada, Barcelona, Spain
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • L'Hospitalet de Llobregat, Barcelona, Spain
  • Martorell, Barcelona, Spain
  • Sabadell, Barcelona, Spain
  • Sant Boi de Llobregat, Barcelona, Spain
  • Sant Cugat del Vallès, Barcelona, Spain
  • Viladecans, Barcelona, Spain
  • Arrecife, Canary Islands, Spain
  • Logroño, La Rioja, Spain
  • San Javier, Murcia, Spain
  • Gijón, Principality of Asturias, Spain
  • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
  • Reus, Tarragona, Spain
  • Barcelona, Spain
  • Burgos, Spain
  • Granada, Spain
  • Jaén, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Tarragona, Spain
  • Valladolid, Spain
  • Zaragoza, Spain
  • Vitoria-Gasteiz, Álava, Spain