AdenomyosisNCT06043583
Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis
A study testing Intrauterine device and Uterine artery embolization in people with Adenomyosis, run by Yonsei University at 1 site in South Korea.
Trial summary
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis. Read more about this study
- Who is it for?
- Ages 19 to 48 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Intrauterine device and Uterine artery embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2023to Jul 2025
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)
Who cannot join
- 1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul
Man-Deuk Kim, 82-10-8625-2197, mdkim@yuhs.ac
About this study
Official title: Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
Read the detailed description
Screening
- History, Physical examination
- Laboratory test (Hemoglobin) / MRI
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
Intervention
- Intrauterine device or uterine artery embolization
- Adverse event montoring
Follow-up visit #1 (1 month)
- Vital signs
- blood test (Hemoglobin) / Ultrasound
- Adverse event monitoring
Follow-up visit #2 (3 month)
- MRI only for embolization patients
Follow-up visit #3 (6 months)
- Blood test (Hemoglobin) / Ultrasound
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
Follow-up visit #4 (12months)
- Blood test (Hemoglobin) / Ultrasound
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
- Conditions
- Adenomyosis
- Being tested
- Intrauterine device, Uterine artery embolization
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine deviceProcedure or surgery
The vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut.
Uterine artery embolizationProcedure or surgery
The right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats.
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine device | Active comparator | Not described Receives: Procedure: Intrauterine device |
| Uterine artery embolization | Active comparator | Not described Receives: Procedure: Uterine artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Hemoglobin as an indicator of menstrual bleeding
Measured: Hemoglobin level at 6 and 12 months after each procedure
Secondary outcomes (4)
Pictorial blood loss assessment chart (PBAC)
Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (>100 considered as heavy mentrual blood)
Measured: 0,6,12 months
Visual analogue scale
Visual analogue scale: a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Measured: 0,6,12 months
Symptom and quality of life score questionnaire
Symptom and quality of life score questionnaire: a questionnaire developed to objectively assess symptom severity and quality of life in relation to uterine adenomyosis before and after procedure
Measured: 0,6,12 months
Uterine volume
Measured: 0,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start21 Jul 2023
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies 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
- None (open label)
- Enrolment
- 56 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
- NCT06043583
- Sponsor's protocol ID
- 4-2023-0729
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy
- ClinicalTrials.gov ID
- NCT06043583
- Acronym / sponsor ID
- 4-2023-0729
- Conditions
- Adenomyosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 21 Sep 2023 (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 the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
Detailed description
Screening
- History, Physical examination
- Laboratory test (Hemoglobin) / MRI
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
Intervention
- Intrauterine device or uterine artery embolization
- Adverse event montoring
Follow-up visit #1 (1 month)
- Vital signs
- blood test (Hemoglobin) / Ultrasound
- Adverse event monitoring
Follow-up visit #2 (3 month)
- MRI only for embolization patients
Follow-up visit #3 (6 months)
- Blood test (Hemoglobin) / Ultrasound
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
Follow-up visit #4 (12months)
- Blood test (Hemoglobin) / Ultrasound
- Pictorial blood loss assessment chart
- Symptom/Quality of life score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine device | Active comparator | Procedure: Intrauterine device |
| Uterine artery embolization | Active comparator | Procedure: Uterine artery embolization |
Who may qualify
- Ages
- 19 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)
Key exclusion criteria (1 listed)
- 1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy
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 |
|---|---|---|
| Intrauterine deviceThe vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut. | Procedure or surgery | Intrauterine device |
| Uterine artery embolizationThe right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats. | Procedure or surgery | Uterine artery embolization |
Primary outcome
Hemoglobin level
Time frame: Hemoglobin level at 6 and 12 months after each procedure
Hemoglobin as an indicator of menstrual bleeding
4 secondary outcomes
Pictorial blood loss assessment chart (PBAC)
Time frame: 0,6,12 months
Visual analogue scale
Time frame: 0,6,12 months
Symptom and quality of life score questionnaire
Time frame: 0,6,12 months
Uterine volume
Time frame: 0,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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 Intrauterine device and Uterine artery embolization in people with Adenomyosis, 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 1 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 21 Sep 2023. 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 Man-Deuk Kim (82-10-8625-2197, mdkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: Hemoglobin level at 6 and 12 months after each procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.