The Affect of Hemostasis With Bipolar Coagulation Versus SURGIFLO Placement on Ovarian Reserve and Future Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Decline in ovarian reserve.
研究概览
简要总结
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (FSH), lutenizing hormone (LH), Estrogen (E2), Progesterone and anti-mullerian hormone (AMH) levels, and sonographic evaluation of ovarian volume and antral follicle count.
详细描述
Patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the SURGIFLO group.
Patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including FSH, LH, E2, Progesterone and AMH levels, and sonographic evaluation of ovarian volume and antral follicle count.
Antral follicle count will be performed on the cyst post-surgery using light microscopy. The difference in hormone levels, especially AMH reflects the damage done during surgery to the ovarian reserve. Sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with benign ovarian cysts that are interested in future fertility ages 18-44.
排除标准
- •Female patients with malignant ovarian cysts/masses.
结局指标
主要结局
Decline in ovarian reserve.
时间窗: Up to 6 months.
Decline rate of AMH levels before and 6 months after surgery.
次要结局
- Number of antral follicles in the cyst removed from the ovary.(Up to 6 months.)
- Changes in Progesterone levels(Up to 6 months)
- Changes in E2 levels(Up to 6 months)
- Sonographic decline in ovarian antral follicle count(Up to 6 months)
- Changes in FSH levels(Up to 6 months.)
- Sonographic decline in ovarian volume(Up to 6 months)
- Changes in LH levels(Up to 6 months)
研究者
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus