The Effects of the Female Hormones on Cerebral Perfusion

Sponsor
University Ghent
Study ID
NCT03299179
Status
Recruiting
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Conditions

  • Cerebral Perfusion
  • Contraception
  • Menstrual Cycle

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • MRI scan — DEVICE
    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).
  • Physiological monitoring — DEVICE
    During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
  • Blood sample — BIOLOGICAL
    Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
  • Blood pressure measurement — DEVICE
    Measuring blood pressure before and after MRI-scan
  • Body temperature — DEVICE
    Measuring body temperature before and after MRI-scan
  • Questionnaires — OTHER
    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.)
  • Pregnancy test — DIAGNOSTIC_TEST
    Test for pregnancy using a pregnancy dipstick test

Study Details

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.

Key Dates

First listed
Oct 2, 2017
Start date
Oct 3, 2016
Status verified
Dec 2023
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
62 participants (estimated)

Arms

  • Arm: Natural cycle
    15 female volunteers, not using hormonal contraception, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 3 times: during the follicular phase, during ovulation and during luteal phase.
  • Arm: Anti-conception
    15 female volunteers, using hormonal contraception pill Deso 20, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 2 times: during the pill-week and during the pill-free week.

Primary Outcome Measure

Regional cerebral perfusion (ml/100g/min): natural versus contraception [ Time Frame: measured during scan-session ]

Central Contacts

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