Clinical trial NCT03299179: The Effects of the Female Hormones on Cerebral Perfusion
Official title: The Effects of the Female Sex Hormones and Hormonal Contraception on Cerebral Perfusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Perfusion
Contraception
Menstrual Cycle
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.

Brief 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 criteria: 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

Primary outcomes:
measure: Regional cerebral perfusion (ml/100g/min): natural versus contraception
timeFrame: measured during scan-session
measure: Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle
timeFrame: measured during scan-session
measure: Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception
timeFrame: measured during scan-session
Secondary outcomes:
measure: Regional grey matter volume (mm³): natural versus contraception
timeFrame: measured during scan-session
measure: Regional grey matter volume (mm³) variations during natural menstrual cycle
timeFrame: measured during scan-session
measure: Regional grey matter volume (mm³) variations during menstrual cycle using contraception
timeFrame: measured during scan-session
measure: Resting state brain activity: natural versus contraception
timeFrame: measured during scan-session
measure: Resting state brain activity variations during natural menstrual cycle
timeFrame: measured during scan-session
measure: Resting state brain activity variations during menstrual cycle using contraception
timeFrame: measured during scan-session
measure: Cerebral diffusion properties: natural versus contraception
timeFrame: measured during scan-session
measure: Cerebral diffusion properties variations during natural menstrual cycle
timeFrame: measured during scan-session
measure: Cerebral diffusion properties variations during menstrual cycle using contraception
timeFrame: measured during scan-session
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Eric Achten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: