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

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called ultrasound-guided alcohol sclerotherapy to see if it can help reduce pelvic pain and improve quality of life for women aged 18 to 45 who have ovarian endometriomas, which are cysts caused by a condition called endometriosis. The researchers want to find out if this treatment is more effective than simply monitoring the condition without immediate intervention, a strategy known as expectant management. Participants will be randomly placed into one of two groups: one will receive the sclerotherapy treatment, while the other will continue with standard monitoring. They will complete assessments about their pain and quality of life before and after six months, and some will also provide blood and urine samples for further analysis.

To be eligible for this trial, women must be between 18 and 45 years old and have specific characteristics related to their endometriomas, including the size of the cysts and certain blood marker levels. Those with a history of certain cancers or who are pregnant, among other criteria, cannot participate. This study is important because it seeks to find a potential new way to help women suffering from pelvic pain due to endometriosis, and it will carefully monitor participants for any side effects or changes in their condition throughout the trial.

Gender

FEMALE

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