Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

NCT06043583 | Unknown DMC

• 1 other identifier: 4-2023-0729
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  Hemoglobin as an indicator of menstrual bleeding

  Hemoglobin level at 6 and 12 months after each procedure

Secondary Outcomes (4)

• Pictorial blood loss assessment chart (PBAC)

  0,6,12 months

• Visual analogue scale

  0,6,12 months

• Symptom and quality of life score questionnaire

  0,6,12 months

• Uterine volume

  0,12 months

Study Arms (2)

Intrauterine device

ACTIVE COMPARATOR

Procedure: Intrauterine device

Uterine artery embolization

ACTIVE COMPARATOR

Procedure: Uterine artery embolization

Interventions

Intrauterine device PROCEDURE

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.

Intrauterine device

Uterine artery embolization PROCEDURE

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.

Uterine artery embolization

Eligibility Criteria

• Age: 19 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Adenomyosis

Interventions

Intrauterine Devices; Uterine Artery Embolization

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies; Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Man-Deuk Kim

CONTACT

82-10-8625-2197; mdkim@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: July 21, 2023
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)