Cerebral Perfusion, Contraception, Menstrual Cycle
Conditions
Brief summary
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
DEVICEMRI 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).
DEVICEPhysiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
BIOLOGICALBlood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
DEVICEBlood pressure measurement
Measuring blood pressure before and after MRI-scan
DEVICEBody temperature
Measuring body temperature before and after MRI-scan
OTHERQuestionnaires
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_TESTPregnancy test
Test for pregnancy using a pregnancy dipstick test
Sponsors
University Ghent
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional cerebral perfusion (ml/100g/min): natural versus contraception | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting state brain activity: natural versus contraception | measured during scan-session | Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception |
| Resting state brain activity variations during natural menstrual cycle | measured during scan-session | 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 |
| Resting state brain activity variations during menstrual cycle using contraception | measured during scan-session | 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 |
| Regional grey matter volume (mm³): natural versus contraception | measured during scan-session | Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception |
| Cerebral diffusion properties variations during natural menstrual cycle | measured during scan-session | 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 |
| Cerebral diffusion properties variations during menstrual cycle using contraception | measured during scan-session | 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 |
| Cerebral diffusion properties: natural versus contraception | measured during scan-session | 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 |
| Regional grey matter volume (mm³) variations during natural menstrual cycle | measured during scan-session | 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 |
| Regional grey matter volume (mm³) variations during menstrual cycle using contraception | measured during scan-session | 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 |
Countries
Belgium
Contacts
Primary ContactPatricia Clement, Msc
Outcome results
None listed