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Recruiting NCT03299179

The Effects of the Female Hormones on Cerebral Perfusion

— Observational Cerebral Perfusion Contraception Menstrual Cycle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI scan, Physiological monitoring, Blood sample, Blood pressure measurement.
Who it may be relevant to
Registry conditions: Cerebral Perfusion, Contraception, Menstrual Cycle. Basic parameters: 18 years — 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device MRI scan
    Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).
  • Device Physiological monitoring
    During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
  • Biological Blood sample
    Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
  • Device Blood pressure measurement
    Measuring blood pressure before and after MRI-scan
  • Device Body temperature
    Measuring body temperature before and after MRI-scan
  • Other Questionnaires
    Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)
  • Diagnostic test Pregnancy test
    Test for pregnancy using a pregnancy dipstick test

Primary outcome measures

  • Regional cerebral perfusion (ml/100g/min): natural versus contraception [Time frame: measured during scan-session]
  • Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle [Time frame: measured during scan-session]
  • Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception [Time frame: measured during scan-session]
Secondary outcome measures (9)
  • Regional grey matter volume (mm³): natural versus contraception [Time frame: measured during scan-session]
  • Regional grey matter volume (mm³) variations during natural menstrual cycle [Time frame: measured during scan-session]
  • Regional grey matter volume (mm³) variations during menstrual cycle using contraception [Time frame: measured during scan-session]
  • Resting state brain activity: natural versus contraception [Time frame: measured during scan-session]
  • Resting state brain activity variations during natural menstrual cycle [Time frame: measured during scan-session]
  • Resting state brain activity variations during menstrual cycle using contraception [Time frame: measured during scan-session]
  • Cerebral diffusion properties: natural versus contraception [Time frame: measured during scan-session]
  • Cerebral diffusion properties variations during natural menstrual cycle [Time frame: measured during scan-session]
  • Cerebral diffusion properties variations during menstrual cycle using contraception [Time frame: measured during scan-session]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Identifiers

NCT: NCT03299179 · EC/2016/0757

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗