Status:
RECRUITING
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Endometrioma
Ultrasound Therapy; Complications
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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, ...
Detailed Description
Endometriosis is a chronic gynecological disease that affects women of reproductive age, characterized by the abnormal growth of endometrial tissue outside the uterine cavity. It affects 5-10% of wom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06955221
Start Date
January 1 2025
End Date
December 31 2027
Last Update
November 20 2025
Active Locations (26)
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1
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07210
2
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital General de Granollers
Granollers, Barcelona, Spain, 08042
4
Consorci Sanitari de l'Anoia
Igualada, Barcelona, Spain, 08700