The Effects of the Female Hormones on Cerebral Perfusion

Recruiting

• Conditions: Cerebral Perfusion; Menstrual Cycle; Contraception
• Interventions: Device: MRI scan; Device: Physiological monitoring; Biological: Blood sample; Device: Blood pressure measurement; Device: Body temperature; Other: Questionnaires; Diagnostic Test: Pregnancy test

• Registration Number: NCT03299179
• Lead Sponsor: University Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natural cycle	Blood pressure measurement	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.
Anti-conception	Blood pressure measurement	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.
Natural cycle	MRI scan	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.
Natural cycle	Questionnaires	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.
Anti-conception	Blood sample	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.
Natural cycle	Physiological monitoring	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.
Natural cycle	Pregnancy test	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.
Anti-conception	MRI scan	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.
Anti-conception	Body temperature	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.
Anti-conception	Questionnaires	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.
Natural cycle	Blood sample	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.
Natural cycle	Body temperature	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.
Anti-conception	Physiological monitoring	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.

Primary Outcome Measures

Name	Time	Method
Regional cerebral perfusion (ml/100g/min): natural versus contraception	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	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	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 Outcome Measures

Name	Time	Method
Regional grey matter volume (mm³): natural versus contraception	measured during scan-session	Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception
Resting state brain activity variations during natural menstrual cycle	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
Resting state brain activity: natural versus contraception	measured during scan-session	Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception
Cerebral diffusion properties: natural versus contraception	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
Cerebral diffusion properties variations during menstrual cycle using contraception	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
Resting state brain activity variations during menstrual cycle using contraception	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
Regional grey matter volume (mm³) variations during natural menstrual cycle	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
Regional grey matter volume (mm³) variations during menstrual cycle using contraception	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
Cerebral diffusion properties variations during natural menstrual cycle	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

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium