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临床试验/NCT03299179
NCT03299179招募中不适用

The Effects of the Female Sex Hormones and Hormonal Contraception on Cerebral Perfusion

University Ghent1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
1
主要终点
Regional cerebral perfusion (ml/100g/min): natural versus contraception

研究概览

简要总结

Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain activity, brain connectivity and white matter diffusion) caused by the female sex hormones and hormonal contraception.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Bachelor or Master student
  • Minimum of 3 months not using contraception of using Deso20

排除标准

  • No informed consent
  • MRI-contraindications
  • Claustrophobia
  • Pregnancy or breastfeeding
  • Chronic diseases and chronic medication use
  • Abuse of alcohol and caffeine

结局指标

主要结局

Regional cerebral perfusion (ml/100g/min): natural versus contraception

时间窗: measured during scan-session

Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception

Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle

时间窗: measured during scan-session

Variations in cerebral perfusion during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample

Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception

时间窗: measured during scan-session

Variations in cerebral perfusion during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample

次要结局

  • Regional grey matter volume (mm³): natural versus contraception(measured during scan-session)
  • Resting state brain activity variations during natural menstrual cycle(measured during scan-session)
  • Resting state brain activity: natural versus contraception(measured during scan-session)
  • Cerebral diffusion properties: natural versus contraception(measured during scan-session)
  • Cerebral diffusion properties variations during menstrual cycle using contraception(measured during scan-session)
  • Resting state brain activity variations during menstrual cycle using contraception(measured during scan-session)
  • Regional grey matter volume (mm³) variations during natural menstrual cycle(measured during scan-session)
  • Regional grey matter volume (mm³) variations during menstrual cycle using contraception(measured during scan-session)
  • Cerebral diffusion properties variations during natural menstrual cycle(measured during scan-session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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