An interventional study of Ultrasound-guided aspiration and alcohol sclerotherapy in Endometrioma, Ultrasound Therapy; Complications and Quality of Life, sponsored by Hospital Universitari de Bellvitge. Recruiting at 26 sites in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment
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:
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:
The study will follow an intention-to-treat and per-protocol analysis approach.
Endometriosis is a chronic gynecological disease that affects women of reproductive age, characterized by the abnormal growth of endometrial tissue outside the uterine cavity.
It affects 5-10% of women of reproductive age (Becker et al., 2022) and is associated with infertility in 40% of cases (Coccia et al., 2008). Among its clinical forms, ovarian endometrioma is the most frequent, appearing in 15-45% of patients with endometriosis (Cranney et al., 2017). In addition to its impact on fertility, the main clinical manifestation of endometriosis is pain. Chronic pelvic pain caused by endometriosis can be disabling and even lead to work absenteeism, with a significant impact on the quality of life of affected patients, who often experience delayed diagnosis, making its management even more difficult and requiring a multidisciplinary approach (Horne \& Missmer, 2022).
Currently, there is still no consensus on what should be the first-line treatment for ovarian endometrioma (Gordts \& Campo, 2019). However, cystectomy reduces ovarian reserve due to the removal of healthy ovarian tissue adjacent to the cyst wall-something that further worsens the reproductive prognosis in patients whose fertility is already diminished due to endometriosis per se (Alborzi et al., 2021; Martinez-Garcia et al., 2021). Moreover, despite surgical removal of the endometrioma, the recurrence rate is high, ranging from 15-30% (Jee, 2022).
In recent years, there has been a shift toward more conservative treatments for the management of endometrioma, such as expectant management or aspiration and sclerosis (Garcia-Tejedor et al., 2020). Various authors have shown that ultrasound-guided aspiration and alcohol sclerosis may be a promising option, as concluded in the meta-analysis by Cohen et al., which found that recurrence rates were similar to those of laparoscopic management of ovarian endometrioma, but with fewer complications. Results in assisted reproductive technology are also better compared to surgical treatment in symptomatic women, particularly in those with low ovarian reserve (Zhang et al., 2022). Furthermore, other comparative studies between surgery and aspiration-sclerosis have shown that, although recurrence rates are similar, pregnancy rates are higher in patients treated with sclerosis, with the same complication rate and significantly lower costs (Garcia-Tejedor et al., 2020; Zhang et al., 2022).
Currently, the first-line treatment in patients diagnosed with endometriosis is hormonal therapy through the use of hormonal contraceptives. However, its efficacy in managing endometrioma is lower, and therefore, there is no consensus on its indication for this specific form of endometriosis (Cranney et al., 2017). In patients with a desire for pregnancy, alternative approaches are sought that do not interfere with fertility. At present, this often involves proceeding with in vitro fertilization without treating the endometrioma first, followed by surgery if needed (Miquel et al., 2020).
In addition to reproductive outcomes in patients affected by endometriosis, symptomatology and its consequent impact on quality of life have become highly relevant factors in treatment selection. Accordingly, specific pain scales and quality-of-life questionnaires have been developed to assess the impact on women affected by this condition. One such tool is the Endometriosis Health Profile scale, available in two versions (EHP-30 and EHP-5), designed by Dr. Stephen Kennedy and his team at the University of Oxford. It is a validated scale for assessing quality of life in patients with endometriosis and has been translated into nearly all languages (Jones et al., 2023; Bourdel et al., 2019).
The main objective of this project is to conduct a comparative analysis of patients diagnosed with ovarian endometrioma who undergo alcohol aspiration and sclerosis versus patients managed expectantly.
The outcomes to be evaluated include impact on quality of life, clinical improvement, pregnancy rate, and the need for subsequent surgery.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 288 is above the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
US-guided alcohol sclerotherapy of endometriomas with absolute etanol during 15 minutes, followed by a posterior wash.
Procedure: Ultrasound-guided aspiration and alcohol sclerotherapy
Expectant management with standard pain management if required
Ultrasound-guided puncture and alcohol sclerotherapy
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 months
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 months
Changes in pain-associated biomarkers 1
Blood: cortisol
Time frame: Baseline and at 6 months
Changes in pain-associated biomarkers 2
Blood: CRP
Time frame: Baseline and at 6 months
Changes in pain-associated biomarkers 3
Blood: IL-6
Time frame: Baseline and at 6 months
Changes in pain-associated biomarkers 4
Urine: cortisol
Time frame: Baseline and at 6 months
Changes in pain-associated biomarkers 5
Urine: adrenaline
Time frame: Baseline and at 6 months
Changes in pain-associated biomarkers 6
Urine: noradrenaline
Time frame: Baseline and at 6 months
Fertility preservation
Blood test: Antimullerian Hormone
Time frame: Baseline and at 6 months
Antral follicle
Antral follicle count by US
Time frame: Baseline and at 6 months
Pregnancy
Number of spontaneous pregnancies or pregnancies achieved through assisted reproductive techniques. Time to Conception
Time frame: Through study completion, an average of 2 years
Reduction in cyst size
Largest diameter
Time frame: Baseline and at 6 months
Adverse events and complications
Registered by Clavien-Dindo classification
Time frame: Baseline and at 6 months
Misdiagnosed cysts
Number of patients with alternative diagnosis
Time frame: During procedure
Healthcare costs
Direct and indirect treatment-related costs; cost-effectiveness analysis
Time frame: Baseline to 6 months
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 23 months is close to that.
Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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