NCT03299179

The Effects of the Female Hormones on Cerebral Perfusion

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cerebral Perfusion
• Contraception
• Menstrual Cycle

Interventions

Type	Name	Description
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).
DEVICE	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
DEVICE	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

Timeline

• Start date: 2016-10-03
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2017-10-02
• Last updated: 2023-12-06

Locations

1 site across 1 country: Belgium