NCT06043583招募中不适用
Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic fibroids (age: 19 - 48 years old)
- •Hemglobin < 12g/dL,
- •Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)
排除标准
- •Gynecologic malignancy
- •Ongoing infection or inflammation
- •Coagulopathy (platelet < 50,000 or INR > 1.5)
- •Concomitant endometriosis
结局指标
主要结局
Hemoglobin level
时间窗: Hemoglobin level at 6 and 12 months after each procedure
Hemoglobin as an indicator of menstrual bleeding
次要结局
- Uterine volume(0,12 months)
- 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)
研究者
研究点 (1)
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