Cerebral PerfusionNCT03299179
The Effects of the Female Hormones on Cerebral Perfusion
An observational study of Cerebral Perfusion and Contraception, run by University Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cerebral Perfusion, Contraception, Menstrual Cycle
- What is being tested?
- MRI scan, Physiological monitoring and Blood sample
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2016to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.
Who may be able to join
- Bachelor or Master student
- Minimum of 3 months not using contraception of using Deso20
Who cannot join
- No informed consent
- MRI-contraindications
- Claustrophobia
- Pregnancy or breastfeeding
- Chronic diseases and chronic medication use
- Smoker
- Drug use
- Abuse of alcohol and caffeine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Patricia Clement, MSc, 477566590 ext. +32, patricia.clement@ugent.be
About this study
Official title: 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.
- Conditions
- Cerebral Perfusion, Contraception, Menstrual Cycle
- Being tested
- MRI scan, Physiological monitoring, Blood sample, Blood pressure measurement, Body temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDevice
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 monitoringDevice
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Blood sampleBiological
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Blood pressure measurementDevice
Measuring blood pressure before and after MRI-scan
Body temperatureDevice
Measuring body temperature before and after MRI-scan
QuestionnairesOther
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 testDiagnostic test
Test for pregnancy using a pregnancy dipstick test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI scan; Device: Physiological monitoring; Biological: Blood sample; Device: Blood pressure measurement; Device: Body temperature; Other: Questionnaires; Diagnostic Test: Pregnancy 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. Receives: Device: MRI scan; Device: Physiological monitoring; Biological: Blood sample; Device: Blood pressure measurement; Device: Body temperature; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
Secondary outcomes (9)
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
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: measured during scan-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start3 Oct 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PerfusionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Achten, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299179
- Sponsor's protocol ID
- EC/2016/0757
- Status last verified
- Dec 2023
- First submitted
- 27 Sep 2017
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Female Sex Hormones and Hormonal Contraception on Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT03299179
- Acronym / sponsor ID
- EC/2016/0757
- Conditions
- Cerebral Perfusion, Contraception, Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | – | Device: MRI scan, Device: Physiological monitoring, Biological: Blood sample, Device: Blood pressure measurement, Device: Body temperature, Other: Questionnaires, Diagnostic Test: Pregnancy test15 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. |
| Anti-conception | – | Device: MRI scan, Device: Physiological monitoring, Biological: Blood sample, Device: Blood pressure measurement, Device: Body temperature, Other: Questionnaires15 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.
Key inclusion criteria (2 listed)
- Bachelor or Master student
- Minimum of 3 months not using contraception of using Deso20
Key exclusion criteria (8 listed)
- No informed consent
- MRI-contraindications
- Claustrophobia
- Pregnancy or breastfeeding
- Chronic diseases and chronic medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanSeveral 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 | Anti-conception, Natural cycle |
| Physiological monitoringDuring MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance | Device | Anti-conception, Natural cycle |
| Blood sampleBlood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone. | Biological | Anti-conception, Natural cycle |
| Blood pressure measurementMeasuring blood pressure before and after MRI-scan | Device | Anti-conception, Natural cycle |
| Body temperatureMeasuring body temperature before and after MRI-scan | Device | Anti-conception, Natural cycle |
| QuestionnairesQuestionnaires 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.) | Other | Anti-conception, Natural cycle |
| Pregnancy testTest for pregnancy using a pregnancy dipstick test | Diagnostic test | Natural cycle |
Primary outcome
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
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
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
9 secondary outcomes
Regional grey matter volume (mm³): natural versus contraception
Time frame: measured during scan-session
Regional grey matter volume (mm³) variations during natural menstrual cycle
Time frame: measured during scan-session
Regional grey matter volume (mm³) variations during menstrual cycle using contraception
Time frame: measured during scan-session
Resting state brain activity: natural versus contraception
Time frame: measured during scan-session
Resting state brain activity variations during natural menstrual cycle
Time frame: measured during scan-session
Resting state brain activity variations during menstrual cycle using contraception
Time frame: measured during scan-session
Cerebral diffusion properties: natural versus contraception
Time frame: measured during scan-session
Cerebral diffusion properties variations during natural menstrual cycle
Time frame: measured during scan-session
Cerebral diffusion properties variations during menstrual cycle using contraception
Time frame: measured during scan-session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Achten, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Perfusion and Contraception, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Clement, Msc (9 332 1330 ext. +32, patricia.clement@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional cerebral perfusion (ml/100g/min): natural versus contraception (time frame: measured during scan-session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.