NCT06043583

Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 19 Years – 48 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adenomyosis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-07-21
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: South Korea