Health TrialsbyHealthPanel

The Effects of the Female Hormones on Cerebral Perfusion

ConditionsCerebral PerfusionContraceptionMenstrual Cycle
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-25
SponsorUniversity Ghent

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Bachelor or Master student

Minimum of 3 months not using contraception of using Deso20

Disqualifiers

No informed consent

MRI-contraindications

Claustrophobia

Pregnancy or breastfeeding

Trial population

30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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/Vaccine

    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 intervention

    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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Natural cycle7 interventions
Group B: Anti-conception6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
measured during scan-session
2

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

Time frame
measured during scan-session
3

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

Time frame
measured during scan-session

Secondary outcomes

1

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

Time frame
measured during scan-session
2

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

Time frame
measured during scan-session
3

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

Time frame
measured during scan-session
4

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

Time frame
measured during scan-session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Ghent

Lead sponsor

Source ClinicalTrials.gov
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