Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHospital Universitari de Bellvitge
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-guided aspiration and alcohol sclerotherapy
Procedure/SurgeryUltrasound-guided puncture and alcohol sclerotherapy
Treatment groups
288 Participants
are divided into 2 treatment groupsGroup A: Ultrasound-guided aspiration and alcohol sclerotherapyExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Quality of Life of patients with endometrioma
Endometriosis Health Profile-5 (EHP-5), the minimum and maximum values (1-5), higher scores mean a worse outcome.
Time frame
Baseline and at 6 monthsSecondary outcomes
1
Pelvic pain
Visual Analog Score for pain (dysmenorrhea), the minimum and maximum values (0-10), higher scores mean a worse outcome.
Time frame
Baseline and at 6 months2
Changes in pain-associated biomarkers 1
Blood: cortisol
Time frame
Baseline and at 6 months3
Changes in pain-associated biomarkers 2
Blood: CRP
Time frame
Baseline and at 6 months4
Changes in pain-associated biomarkers 3
Blood: IL-6
Time frame
Baseline and at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari de Bellvitge
Lead sponsor
Carlos III Health Institute
Collaborator
Source ClinicalTrials.gov