A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
研究概览
简要总结
Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned.
The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.
详细描述
Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-40 years
- •ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and 10cm
- •no clinical and sonographic suspicion of ovarian cancer
- •regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery
- •sonographic normal contralateral ovary
- •agreement to be enrolled in the study.
排除标准
- •prior ovarian surgery or known endocrine disease
- •surgical necessity to perform adnexectomy
- •intraoperative diagnosis of an abnormal contralateral ovary
- •post operative pathologic diagnosis was not benign ovarian cyst
- •oral contraceptive use before surgery.
结局指标
主要结局
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
时间窗: 12 months
次要结局
- Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity(12 months)