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

NCT06955221 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Endometrioma
  • Ultrasound Therapy; Complications
  • Quality of Life
  • Pelvic Pain

Interventions

PROCEDURE

Ultrasound-guided aspiration and alcohol sclerotherapy

Ultrasound-guided puncture and alcohol sclerotherapy

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Amparo Garcia-Tejedor, MDPhD · Hospital Universitario de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955221 on ClinicalTrials.gov