Ovarian EndometriomaNCT05279209
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
A study testing catheter-directed sclerotherapy and surgical resection in people with Ovarian Endometrioma, run by Yonsei University at 1 site in South Korea.
Trial summary
The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma Read more about this study
- Who is it for?
- Ages 19 to 60 years, women only
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- catheter-directed sclerotherapy and surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Dec 2021to 17 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women with symptomatic fibroids (age: 20 - 60 years old)
Who cannot join
- Gynecologic malignancy
- Ongoing infection or inflammation
- Coagulopathy (platelet < 50,000 or INR > 1.5)
- Extraovarian endometriosis
- Serum AMH of 5 or higher
- Drug allergy
- Illiteracy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Kichang Han, 82-10-9722-6315, wowsaycheese@yuhs.ac
About this study
The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma
Read the detailed description
Screening
- History, Physical examination
- Vital signs
- Laboratory test (Serum AMH, CA-125, HE-4) / EKG / MRI
- EHP-30
Intervention
- Surgical enucleation or catheter-directed sclerotherapy
- Laboratory test / EKG
- Adverse event monitoring
Follow-up visit #1 (1 month)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound
- Adverse event monitoring
Follow-up visit #2 (6 months)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound / Contrast-enhanced MRI
- EHP-30
Follow-up visit #3 (12months)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound
- EHP-30
- Conditions
- Ovarian Endometrioma
- Being tested
- catheter-directed sclerotherapy, surgical resection
- Keywords
- Endometrioma, resection, enucleation, sclerotherapy, ovarian function
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter-directed sclerotherapyProcedure or surgery
Ovarian endometrioma is targeted under transvaginal/transabdominal ultrasound. A guidewire is inserted to the lesion and is exchanged for a catheter. The cystic content is thoroughly aspirated and then sclerotherapy is performed by injecting 99% ethanol.
surgical resectionProcedure or surgery
Surgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| Sclerotherapy | Experimental | Patients who receive uterine artery embolization for symptomatic fibroids Receives: Procedure: catheter-directed sclerotherapy |
| Surgery | Active comparator | Patients who receive uterine artery embolization for symptomatic fibroids Receives: Procedure: surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum AMH
Serum AMH: A measure of ovarian function
Measured: Serum AMH at 1month after catheter-directed sclerotherapy
Serum AMH
Serum AMH: A measure of ovarian function
Measured: Serum AMH at 6months after catheter-directed sclerotherapy
Serum AMH
Serum AMH: A measure of ovarian function
Measured: Serum AMH at 12 months after catheter-directed sclerotherapy
Secondary outcomes (4)
Recurrence
Recurrence of symptoms or development of ovarian endometrioma of 2cm or larger on follow-up imaging (surgery) vs. Recurrence of symptoms or detection of the lesion 50% or larger to the size of the initial lesion on follow-up imaging (sclerotherapy).
Measured: 1, 6, and 12 months
hospital stay
Time from admission to discharge
Measured: duration of admission (days), up to 5 days
serum CA-125
Serum CA-125 (unit/mL): Surrogate marker for therapeutic efficacy (A reduction in serum CA-125 represents a response to the intervention)
Measured: 1, 6, 12 months
EHP-30 (Endometriosis Health Profile-30)
EHP-30: A measure of quality of life related to ovarian endometrioma (Scale of 0 to 30, A higher score represents adverse impact of daily living by the endometriosis)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start18 Dec 2021
- Primary completion17 Dec 2022 (estimated)
- Study completion17 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279209
- Sponsor's protocol ID
- 4-2021-1512
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang M, Seo SK, Kim MD, Kim HY, Kwon JH, Kim GM, Park J, Cho J, Jeong SM, Won JY, Alanazi MS, Alqarni AA, Han K. Catheter-Directed Sclerotherapy Versus Ovarian Cystectomy for Unilateral Ovarian Endometrioma: A Pilot Randomized Controlled Trial. AJR Am J Roentgenol. 2026 Jul;227(1):e2534498. doi: 10.2214/AJR.25.34498. Epub 2026 Mar 25.
PubMed 41879728
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT05279209
- Acronym / sponsor ID
- 4-2021-1512
- Conditions
- Ovarian Endometrioma
- Keywords
- Endometrioma, resection, enucleation, sclerotherapy, ovarian function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 17 Dec 2022 (estimated)
- Study completion
- 17 Dec 2023 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma
Detailed description
Screening
- History, Physical examination
- Vital signs
- Laboratory test (Serum AMH, CA-125, HE-4) / EKG / MRI
- EHP-30
Intervention
- Surgical enucleation or catheter-directed sclerotherapy
- Laboratory test / EKG
- Adverse event monitoring
Follow-up visit #1 (1 month)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound
- Adverse event monitoring
Follow-up visit #2 (6 months)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound / Contrast-enhanced MRI
- EHP-30
Follow-up visit #3 (12months)
- Vital signs
- Lab test (AMH, CA-125) / Ultrasound
- EHP-30
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sclerotherapy | Experimental | Procedure: catheter-directed sclerotherapyPatients who receive uterine artery embolization for symptomatic fibroids |
| Surgery | Active comparator | Procedure: surgical resectionPatients who receive uterine artery embolization for symptomatic fibroids |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women with symptomatic fibroids (age: 20 - 60 years old)
Key exclusion criteria (8 listed)
- Gynecologic malignancy
- Ongoing infection or inflammation
- Coagulopathy (platelet < 50,000 or INR > 1.5)
- Extraovarian endometriosis
- Serum AMH of 5 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter-directed sclerotherapyOvarian endometrioma is targeted under transvaginal/transabdominal ultrasound. A guidewire is inserted to the lesion and is exchanged for a catheter. The cystic content is thoroughly aspirated and then sclerotherapy is performed by injecting 99% ethanol. | Procedure or surgery | Sclerotherapy |
| surgical resectionSurgical resection of the ovarian endometrioma is performed under general anesthesia. To preserve the residual ovarian function, enucleation is the primary surgical technique. | Procedure or surgery | Surgery |
Primary outcome
Serum AMH
Time frame: Serum AMH at 1month after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
Serum AMH
Time frame: Serum AMH at 6months after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
Serum AMH
Time frame: Serum AMH at 12 months after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
4 secondary outcomes
Recurrence
Time frame: 1, 6, and 12 months
hospital stay
Time frame: duration of admission (days), up to 5 days
serum CA-125
Time frame: 1, 6, 12 months
EHP-30 (Endometriosis Health Profile-30)
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 41879728Hwang M, Seo SK, Kim MD, Kim HY, Kwon JH, Kim GM, Park J, Cho J, Jeong SM, Won JY, Alanazi MS, Alqarni AA, Han K. Catheter-Directed Sclerotherapy Versus Ovarian Cystectomy for Unilateral Ovarian Endometrioma: A Pilot Randomized Controlled Trial. AJR Am J Roentgenol. 2026 Jul;227(1):e2534498. doi: 10.2214/AJR.25.34498. Epub 2026 Mar 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheter-directed sclerotherapy and surgical resection in people with Ovarian Endometrioma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kichang Han (82-10-9722-6315, wowsaycheese@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum AMH (time frame: Serum AMH at 1month after catheter-directed sclerotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279209, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.