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NCT Number: NCT03299179

The Effects of the Female Hormones on Cerebral Perfusion

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.

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Key information

Conditions

Cerebral Perfusion Contraception Menstrual Cycle

Age range

18 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Patricia Clement, MSc

CONTACT

[email protected]

477566590 ext. +32

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scan

Device

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

Device

During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance

Blood sample

Biological

Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.

Blood Pressure Measurement

Device

Measuring blood pressure before and after MRI-scan

Body temperature

Device

Measuring body temperature before and after MRI-scan

questionnaires

Other

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.)

pregnancy test

Diagnostic Test

Test for pregnancy using a pregnancy dipstick test

Primary outcomes

  1. Regional cerebral perfusion (ml/100g/min): natural versus contraception

    Time frame: measured during scan-session

    Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception

  2. Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle

    Time frame: measured during scan-session

    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

  3. Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception

    Time frame: measured during scan-session

    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

Secondary outcomes

  1. Regional grey matter volume (mm³): natural versus contraception

    Time frame: measured during scan-session

    Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception

  2. Regional grey matter volume (mm³) variations during natural menstrual cycle

    Time frame: measured during scan-session

    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

  3. Regional grey matter volume (mm³) variations during menstrual cycle using contraception

    Time frame: measured during scan-session

    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

  4. Resting state brain activity: natural versus contraception

    Time frame: measured during scan-session

    Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception

  5. Resting state brain activity variations during natural menstrual cycle

    Time frame: measured during scan-session

    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

  6. Resting state brain activity variations during menstrual cycle using contraception

    Time frame: measured during scan-session

    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

  7. Cerebral diffusion properties: natural versus contraception

    Time frame: measured during scan-session

    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

  8. Cerebral diffusion properties variations during natural menstrual cycle

    Time frame: measured during scan-session

    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

  9. Cerebral diffusion properties variations during menstrual cycle using contraception

    Time frame: measured during scan-session

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Clement, Msc

CONTACT

[email protected]

9 332 1330 ext. +32

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2017
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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