The Effects of the Female Hormones on Cerebral Perfusion

December 5, 2023 updated by: University Ghent

The Effects of the Female Sex Hormones and Hormonal Contraception 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natural cycle
15 female volunteers, not using hormonal contraception, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 3 times: during the follicular phase, during ovulation and during luteal phase.
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
Anti-conception
15 female volunteers, using hormonal contraception pill Deso 20, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 2 times: during the pill-week and during the pill-free week.
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Eric Achten, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • EC/2016/0757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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