The Effects of the Female Hormones on Cerebral Perfusion
NCT ID: NCT03299179
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
62 participants
OBSERVATIONAL
2016-10-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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).
Physiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Body temperature
Measuring body temperature before and after MRI-scan
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.)
Pregnancy test
Test for pregnancy using a pregnancy dipstick test
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.
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).
Physiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Body temperature
Measuring body temperature before and after MRI-scan
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.)
Interventions
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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).
Physiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Body temperature
Measuring body temperature before and after MRI-scan
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.)
Pregnancy test
Test for pregnancy using a pregnancy dipstick test
Eligibility Criteria
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Inclusion Criteria
* Minimum of 3 months not using contraception of using Deso20
Exclusion Criteria
* MRI-contraindications
* Claustrophobia
* Pregnancy or breastfeeding
* Chronic diseases and chronic medication use
* Smoker
* Drug use
* Abuse of alcohol and caffeine
18 Years
25 Years
FEMALE
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Eric Achten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Patricia Clement, MSc
Role: primary
Other Identifiers
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EC/2016/0757
Identifier Type: -
Identifier Source: org_study_id