Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Not Applicable

Recruiting

• Conditions: Adenomyosis
• Interventions: Procedure: Uterine artery embolization; Procedure: Intrauterine device

• Registration Number: NCT06043583
• Lead Sponsor: Yonsei University

Brief Summary

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 Timeline

• Study Start: 2023-07-21
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterine artery embolization	Uterine artery embolization	-
Intrauterine device	Intrauterine device	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	Hemoglobin level at 6 and 12 months after each procedure	Hemoglobin as an indicator of menstrual bleeding

Secondary Outcome Measures

Name	Time	Method
Pictorial blood loss assessment chart (PBAC)	0,6,12 months	Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (\>100 considered as heavy mentrual blood)
Visual analogue scale	0,6,12 months	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.
Symptom and quality of life score questionnaire	0,6,12 months	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
Uterine volume	0,12 months

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of