Actively Recruiting
Effect of Ultrasound-Guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life in Women Aged 18 to 45
Led by Hospital Universitari de Bellvitge · Updated on 2026-05-08
288
Participants Needed
29
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari de Bellvitge
Lead Sponsor
C
Carlos III Health Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of ultrasound-guided alcohol sclerotherapy on pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas. This clinical trial compares sclerotherapy to expectant management to determine if the procedure reduces pelvic pain and improves quality of life, measured by the Endometriosis Health Profile (EHP-5) score. The study addresses the need for less invasive treatment options for ovarian endometrioma, a common form of endometriosis that affects fertility and causes chronic pain. Participants are randomly assigned to either the sclerotherapy group, which undergoes ultrasound-guided puncture and alcohol sclerotherapy with absolute ethanol for 15 minutes followed by a wash, or the control group receiving expectant management with standard pain treatments as needed. The trial follows patients over time to assess pain, quality of life, fertility markers, pregnancy rates, and any adverse events or recurrence. During the study, participants complete baseline and 6-month assessments of pain and quality of life, provide blood and urine samples for biomarker analysis, and undergo ovarian reserve evaluations including AMH and antral follicle counts. Researchers will monitor fertility outcomes and treatment costs with follow-up continuing for about two years to evaluate pregnancy rates. Data will be analyzed using intention-to-treat and per-protocol methods to compare the two groups.
CONDITIONS
Brief Title
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age 18 to 45 years
- Ultrasound shows unilocular endometrioma or with a thin septum less than 3 mm
- Endometrioma size between 30 and 100 mm, persistent for at least 3 to 6 months since diagnosis
- Ca125 marker less than 300 UI/mL and HE4 less than 70 pM
- Signed informed consent
You will not qualify if you...
- Age under 18 or over 45 years
- History of ovarian or uterine cancer
- Endometrioma size less than 30 mm or greater than 100 mm
- Need for surgical treatment due to severe extra-ovarian endometriosis or other causes
- Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy
- Ca125 greater than 300 UI/mL
- HE4 greater than 70 pM
- Pregnant women
- Patients unwilling to participate or mentally incapacitated
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up through 6 months
Participants receive ultrasound-guided aspiration and alcohol sclerotherapy or are managed expectantly with standard pain management if required.
1 treatment visit and follow-up visits at baseline and 6 months
Duration - Up to 2 years
Participants are followed to assess pelvic pain, quality of life, fertility preservation, and pregnancy outcomes.
Visits at baseline, 6 months, and periodic assessments up to 2 years
Trial Site Locations
Total: 29 locations
1
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07210
Not Yet Recruiting
2
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Not Yet Recruiting
3
Hospital General de Granollers
Granollers, Barcelona, Spain, 08042
Not Yet Recruiting
4
Consorci Sanitari de l'Anoia
Igualada, Barcelona, Spain, 08700
Not Yet Recruiting
5
Consorci Sanitari Integral
L'Hospitalet de Llobregat, Barcelona, Spain, 08906
Actively Recruiting
6
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
7
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
8
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, Spain, 08830
Not Yet Recruiting
9
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Not Yet Recruiting
10
Hospital de Viladecans
Viladecans, Barcelona, Spain, 08840
Actively Recruiting
11
Hospital Universitario Doctor José Molina Orosa
Arrecife, Canary Islands, Spain, 35500
Not Yet Recruiting
12
Hospital Universitario San Pedro
Logroño, La Rioja, Spain, 26006
Not Yet Recruiting
13
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, Spain, 30739
Not Yet Recruiting
14
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain, 33394
Not Yet Recruiting
15
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Not Yet Recruiting
16
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
Not Yet Recruiting
17
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Not Yet Recruiting
18
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
19
Hospital Universitario de Burgos
Burgos, Spain, 09006
Not Yet Recruiting
20
Clínica Sanabria
Granada, Spain, 18012
Not Yet Recruiting
21
Hospital Universitario de Jaén
Jaén, Spain, 23007
Not Yet Recruiting
22
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
23
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
24
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
25
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Not Yet Recruiting
26
Hospital Universitario Joan XXIII
Tarragona, Spain, 43005
Not Yet Recruiting
27
Hospital Recoletas Salud Campo Grande
Valladolid, Spain, 47007
Actively Recruiting
28
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Not Yet Recruiting
29
Hospital Universitario de Álava - Txagorritxu
Vitoria-Gasteiz, Álava, Spain, 01009
Not Yet Recruiting
Research Team
A
Amparo Garcia-Tejedor, MDPhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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