Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Yonsei University

Status: Enrolling

Conditions: Adenomyosis

Treatments: Procedure: Intrauterine device; Procedure: Uterine artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT06043583

4-2023-0729

Details and patient eligibility

About

The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.

Full 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

Enrollment: 56 estimated patients

Sex: Female

Ages: 19 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)

Exclusion criteria

1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Intrauterine device

Active Comparator group

Treatment:

Procedure: Intrauterine device

Uterine artery embolization

Active Comparator group

Treatment:

Procedure: Uterine artery embolization