Comparing intrauterine devices and uterine artery embolization for treating adenomyosis
Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy
This study is testing whether an intrauterine device or a procedure called uterine artery embolization works better for treating adenomyosis in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 19 Years to 48 Years |
| Sex | Female |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06043583 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two treatments for uterine adenomyosis: intrauterine devices and uterine artery embolization. Participants will undergo a thorough screening process, including physical exams, laboratory tests, and MRI scans. They will then receive one of the two interventions and be monitored for adverse events. Follow-up visits will assess vital signs, blood tests, and quality of life over a period of 12 months.
Who should consider this trial
Good fit: Ideal candidates are women aged 19 to 48 with symptomatic adenomyosis and hemoglobin levels below 12g/dL.
Not a fit: Patients with gynecologic malignancies, ongoing infections, or coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with more effective treatment options for managing adenomyosis symptoms.
How similar studies have performed: Other studies have explored similar treatment comparisons, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Severance hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Man-Deuk Kim
- Email: mdkim@yuhs.ac
- Phone: 82-10-8625-2197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.