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

RecruitingNAAges 18 Years - 45 YearsFemaleHospital Universitari de Bellvitge
NCT06955221 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 mont

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📋 Eligibility rules (as published)
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
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What it tests

  • Ultrasound-guided aspiration and alcohol sclerotherapy
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Where

27 sites
Hospital Universitario Son Espases
Palma de Mallorca, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Consorci Sanitari de l'Anoia
Igualada, Spain
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital San Juan de Dios de Martorell
Martorell, Spain
Consorci Corporació Sanitària Parc Taulí
Sabadell, Spain
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Spain

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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