The Effects of the Female Hormones on Cerebral Perfusion

Study Overview
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Brief Summary
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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.

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

Conditions
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Contraception, Cerebral Perfusion, Menstrual Cycle

Intervention / Treatment
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* Device: MRI scan
* Device: Physiological monitoring
* Biological: Blood sample
* Device: Blood pressure measurement
* Device: Body temperature
* Other: Questionnaires
* Diagnostic Test: Pregnancy test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Natural cycle<br>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<br>* 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).<br>Device: Physiological monitoring<br>* During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance<br>Biological: Blood sample<br>* Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.<br>Device: Blood pressure measurement<br>* Measuring blood pressure before and after MRI-scan<br>Device: Body temperature<br>* Measuring body temperature before and after MRI-scan<br>Other: Questionnaires<br>* 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.)<br>Diagnostic Test: Pregnancy test<br>* Test for pregnancy using a pregnancy dipstick test<br>|
| Anti-conception<br>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<br>* 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).<br>Device: Physiological monitoring<br>* During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance<br>Biological: Blood sample<br>* Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.<br>Device: Blood pressure measurement<br>* Measuring blood pressure before and after MRI-scan<br>Device: Body temperature<br>* Measuring body temperature before and after MRI-scan<br>Other: Questionnaires<br>* 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.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | measured during scan-session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | measured during scan-session |