NCT05279209Unknown不适用
Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
适应症
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
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
次要结局
- 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)
- Recurrence(1, 6, and 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian CancerEndometrial NeoplasmsOvarian NeoplasmsNCT01810874Hospital Universitari Vall d'Hebron Research Institute60
Unknown
不适用
The Impact of Surgical Treatment of Endometriomas on Ovarian ReserveEndometriosisNCT01425333Saad Amer20
招募中
不适用
Endometrioma Sclerotherapy and Ovarian PreservationNCT06775769Chelsea and Westminster NHS Foundation Trust60
已完成
4 期
OCP vs Metformin on Ovarian Stromal Blood Flow in PCOSPCOSNCT03236740S.C.B. Medical College and Hospital101
Unknown
不适用
The Clinical Significance of Ovarian Function Detection and Protection in Fertility Preservation Surgery for Ovarian MalignancyFertility Preservation SurgeryOvarian MalignancyNCT03882190Second Affiliated Hospital of Wenzhou Medical University20