Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Change in ovarian reserve
研究概览
简要总结
Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
- •women aged between 19 and 52 years
- •women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
- •women who were appropriated medical status for laparoscopic surgery
排除标准
- •any ovarian cysts requiring ovarian surgery
- •any suspicious findings of malignant diseases
- •history of prior salpingectomy or salpingo-oophorectomy
- •pregnant or menopausal status
- •preoperative serum anti-Müllerian hormone (AMH) < 0.30 ng/mL
- •use of hormonal treatments in the three months before surgery
- •any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
- •an inability to understand and provide written informed consent.
结局指标
主要结局
Change in ovarian reserve
时间窗: 3 months after surgery
The primary outcome measure was the change of ovarian reserve, determined by the rate of decline in AMH level from before surgery to 3-month post-surgery with the following formula : decline rate (%) = 100 × (preoperative AMH level - postoperative AMH level) ÷ preoperative AMH level.
次要结局
未报告次要终点