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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03299179
Other study ID # EC/2016/0757
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2016
Est. completion date December 31, 2027

Study information

Verified date December 2023
Source University Ghent
Contact Patricia Clement, Msc
Phone 9 332 1330
Email patricia.clement@ugent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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
Biological:
Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Device:
Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Body temperature
Measuring body temperature before and after MRI-scan
Other:
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.)
Diagnostic Test:
Pregnancy test
Test for pregnancy using a pregnancy dipstick test

Locations

Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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