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临床试验/NCT01578759
NCT01578759已完成不适用

Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)

研究概览

简要总结

The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

排除标准

  • Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
  • Personal history of gynecologic cancer
  • Pregnancy
  • Non-English speaking
  • Unable to provide informed consent

结局指标

主要结局

Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)

时间窗: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.

次要结局

  • Patient demographics(Prior to surgery)
  • Patient surgical outcomes(Postoperatively on day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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