NCT04757922Enrolling By Invitation不适用
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Menopausal age
研究概览
简要总结
The aim of this study is to evaluate the long-term safety of on the onset of menopause.
详细描述
The aim of this study is to evaluate the long-term safety of on the onset of menopause. To investigate the effect of Opportunistic Salpingectomy on the age of menopause, we will compare age of menopause in women who underwent sterilization through opportunistic salpingectomy with a control group consisting of women who underwent sterilization by tubal ligation or who had no sterilization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Intervention group
- •Undergoing an Opportunistic Salpingectomy as sterilization method
- •Premenopausal status at enrolment
- •Age between 30 and 45 years
- •Will have residual ovarian tissue after surgery
- •Able to understand the written or spoken Dutch language
- •Gives consent for participating in surveys
- •Control group
- •Premenopausal status at enrolment
- •Either sterilization by tubal ligation or no sterilization at all
- •Age between 35 and 45 years
- •Able to understand the written or spoken Dutch language
- •Gives consent for participating in surveys
排除标准
- •Postmenopausal status at enrolment
- •Under the age of 35 or above 45
- •Previous salpingectomy of oophorectomy
- •Previous hysterectomy
- •Women with abnormal karyotype (such as Turner Syndrome and Fragile X syndrome)
- •Underwent chemotherapy or radiation
- •Unable to understand the written or spoken Dutch language
结局指标
主要结局
Menopausal age
时间窗: At end of follow-up (follow up ends at age of menopause with a maximum follow-up time of 15 years)
The age of reaching natural menopause (e.g. last menstruation \> 1 year ago )
次要结局
- Decision regret(1 year post surgery and at age of menopause)
研究者
研究点 (1)
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