Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis
NCT ID: NCT06043583
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2023-07-21
2025-07-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intrauterine device
Intrauterine device
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 embolization
Uterine artery embolization
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.
Interventions
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Intrauterine device
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 embolization
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
48 Years
FEMALE
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2023-0729
Identifier Type: -
Identifier Source: org_study_id
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