The Effects of the Female Hormones on Cerebral Perfusion

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299179
• Other study ID #: EC/2016/0757
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Perfusion
• Contraception
• Menstrual Cycle

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