Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Serum AMH
研究概览
简要总结
The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma
详细描述
Screening
- History, Physical examination
- Vital signs
- Laboratory test (Serum AMH, CA-125, HE-4) / EKG / MRI
- EHP-30
Intervention
- Surgical enucleation or catheter-directed sclerotherapy
- Laboratory test / EKG
- Adverse event monitoring
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with symptomatic fibroids (age: 20 - 60 years old)
排除标准
- •Gynecologic malignancy
- •Ongoing infection or inflammation
- •Coagulopathy (platelet < 50,000 or INR > 1.5)
- •Extraovarian endometriosis
- •Serum AMH of 5 or higher
- •Drug allergy
研究组 & 干预措施
Sclerotherapy
Patients who receive uterine artery embolization for symptomatic fibroids
干预措施: catheter-directed sclerotherapy (Procedure)
Surgery
Patients who receive uterine artery embolization for symptomatic fibroids
干预措施: surgical resection (Procedure)
结局指标
主要结局
Serum AMH
时间窗: Serum AMH at 12 months after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
Serum AMH
时间窗: Serum AMH at 6months after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
Serum AMH
时间窗: Serum AMH at 1month after catheter-directed sclerotherapy
Serum AMH: A measure of ovarian function
次要结局
- Recurrence(1, 6, and 12 months)
- serum CA-125(1, 6, 12 months)
- hospital stay(duration of admission (days), up to 5 days)
- EHP-30 (Endometriosis Health Profile-30)(6 and 12 months)