Alcohol sclerotherapy for pelvic pain and quality of life in ovarian endometrioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women meeting entry criteria are randomly assigned to receive ultrasound-guided aspiration with alcohol sclerotherapy or to expectant management, with outcomes compared at six months. Pain and quality of life are measured using standardized instruments including the EHP-5, and blood and urine samples are collected for biomarkers such as cortisol, IL-6, and hsCRP. The intervention is a minimally invasive outpatient procedure performed under ultrasound guidance, and the control arm receives routine monitoring without immediate intervention. The trial focuses on unilocular or thin-septum endometriomas sized 30–100 mm and excludes cases with suspicion of malignancy or indications for immediate surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Consorci Sanitari de l'Anoia
  Igualada, Barcelona, Spain Recruiting
• Consorci Sanitari Integral
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Universitario de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital de Viladecans
  Viladecans, Barcelona, Spain Recruiting
• Hospital General Universitario Los Arcos del Mar Menor
  San Javier, Murcia, Spain Recruiting
• Hospital del Mar
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Amparo Garcia-Tejedor, MDPhD — Hospital Universitari de Bellvitge
• Study coordinator: Amparo Garcia-Tejedor, MDPhD
• Email: agarciat@bellvitgehospital.cat
• Phone: 34 + 932607695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.