RecruitingNCT03299179

The Effects of the Female Hormones on Cerebral Perfusion

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


Sponsor

University Ghent

Enrollment

62 participants

Start Date

Oct 3, 2016

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how female hormones — particularly those affected by birth control pills — influence blood flow to the brain. It uses MRI brain scans to compare women using hormonal contraception to those who are not. **You may be eligible if...** - You are a university student (bachelor's or master's level) - You have not been using contraception for at least 3 months, OR you are using a specific low-dose contraceptive pill called Deso20 **You may NOT be eligible if...** - You have not given informed consent - You cannot have an MRI scan (e.g., due to metal implants) - You have claustrophobia (fear of enclosed spaces) - You are pregnant or breastfeeding - You have a chronic illness or take regular medication - You smoke, use drugs, or have a history of substance abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Ghent University Hospital

Ghent, Belgium

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NCT03299179


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