An observational study in Cerebral Perfusion, Contraception and Menstrual Cycle, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by University Ghent · Observational
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.
30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.
Exclusion Criteria:
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.
Device: MRI scan · Device: Physiological monitoring · Biological: Blood sample · Device: Blood pressure measurement · Device: Body temperature · Other: Questionnaires · Diagnostic Test: Pregnancy test
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.
Device: MRI scan · Device: Physiological monitoring · Biological: Blood sample · Device: Blood pressure measurement · Device: Body temperature · Other: Questionnaires
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).
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Measuring blood pressure before and after MRI-scan
Measuring body temperature before and after MRI-scan
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.)
Test for pregnancy using a pregnancy dipstick test
Regional cerebral perfusion (ml/100g/min): natural versus contraception
Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception
Time frame: measured during scan-session
Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle
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
Time frame: measured during scan-session
Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception
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
Time frame: measured during scan-session
Regional grey matter volume (mm³): natural versus contraception
Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception
Time frame: measured during scan-session
Regional grey matter volume (mm³) variations during natural menstrual cycle
Variations during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Regional grey matter volume (mm³) variations during menstrual cycle using contraception
Variations in grey matter volume during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Resting state brain activity: natural versus contraception
Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception
Time frame: measured during scan-session
Resting state brain activity variations during natural menstrual cycle
Variations in resting state brain activity during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Resting state brain activity variations during menstrual cycle using contraception
Variations in resting state brain activity during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Cerebral diffusion properties: natural versus contraception
Differences in diffusion properties (Mean Diffusivity(MD)/Apparent Diffusion Coefficient (ADC)/fractional Anisotropy(FA)) between volunteers of the natural cycle group versus the volunteers using contraception
Time frame: measured during scan-session
Cerebral diffusion properties variations during natural menstrual cycle
Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Cerebral diffusion properties variations during menstrual cycle using contraception
Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
Time frame: measured during scan-session
Plan to share: Undecided
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