Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Last updated: September 12, 2023
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Dysfunctional Uterine Bleeding

Treatment

Uterine artery embolization

Intrauterine device

Clinical Study ID

NCT06043583
4-2023-0729
  • Ages 19-48
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Uterine artery embolization
Phase:
Study Start date:
July 21, 2023
Estimated Completion Date:
July 31, 2025

Study 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

Connect with a study center

  • Severance hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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