Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043583

Collaborator

(none)

Enrollment

Location

Arms

23.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis	Procedure: Intrauterine device Procedure: Uterine artery embolization	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 21, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intrauterine device	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.
Active Comparator: Uterine artery embolization	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Intrauterine device

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.

Active Comparator: Uterine artery embolization

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Hemoglobin level [Hemoglobin level at 6 and 12 months after each procedure]
Hemoglobin as an indicator of menstrual bleeding

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 48 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT06043583

Other Study ID Numbers:

4-2023-0729

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenomyosis

Study Results

No Results Posted as of Sep 21, 2023