Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
研究概览
简要总结
The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.
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 (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn
排除标准
- •Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
结局指标
主要结局
Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
时间窗: Baseline and 8 weeks following surgery
AMH levels
次要结局
未报告次要终点
研究者
Hadas Ganer Herman
Dr.
Wolfson Medical Center
