NCT06955221
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Registry fields
- Overall status
- RECRUITING
- Conditions
- Endometrioma, Ultrasound Therapy; Complications, Quality of Life, Pelvic Pain
- Study type
- INTERVENTIONAL
- Phase
- NA
- Primary purpose
- TREATMENT
- Intervention type
- PROCEDURE
- Interventions
- Ultrasound-guided aspiration and alcohol sclerotherapy
- Lead sponsor
- Hospital Universitari de Bellvitge (OTHER)
Cached at: 2026-10-09 01:48:06
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, 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.
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.
Contact
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