Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Adenomyosis Clinical Trial

Official title:

Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043583
• Other study ID #: 4-2023-0729
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Yonsei University
• Contact: Man-Deuk Kim
• Phone: 82-10-8625-2197
• Email: mdkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	Hemoglobin as an indicator of menstrual bleeding	Hemoglobin level at 6 and 12 months after each procedure
Secondary	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)	0,6,12 months
Secondary	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.	0,6,12 months
Secondary	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	0,6,12 months
Secondary	Uterine volume		0,12 months