The Effects of the Female Hormones on Cerebral Perfusion

NCT03299179 | Recruiting

• 1 other identifier: EC/2016/0757
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Perfusion; Contraception; Menstrual Cycle

Outcome Measures

Primary Outcomes (3)

• 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 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 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 during scan-session

Secondary Outcomes (9)

• Regional grey matter volume (mm³): natural versus contraception

  measured during scan-session

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

  measured during scan-session

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

  measured during scan-session

• Resting state brain activity: natural versus contraception

  measured during scan-session

• Resting state brain activity variations during natural menstrual cycle

  measured during scan-session

Study Arms (2)

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; 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.

Device: MRI scan; Device: Physiological monitoring; Biological: Blood sample; Device: Blood pressure measurement; Device: Body temperature; Other: Questionnaires

Interventions

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).

Anti-conception; Natural cycle

Physiological monitoring DEVICE

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

Anti-conception; Natural cycle

Blood sample BIOLOGICAL

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

Anti-conception; Natural cycle

Blood pressure measurement DEVICE

Measuring blood pressure before and after MRI-scan

Anti-conception; Natural cycle

Body temperature DEVICE

Measuring body temperature before and after MRI-scan

Anti-conception; Natural cycle

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.)

Anti-conception; Natural cycle

Pregnancy test DIAGNOSTIC_TEST

Test for pregnancy using a pregnancy dipstick test

Natural cycle

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Bachelor or Master student
• Minimum of 3 months not using contraception of using Deso20

You may not qualify if:

• No informed consent
• MRI-contraindications
• Claustrophobia
• Pregnancy or breastfeeding
• Chronic diseases and chronic medication use
• Smoker
• Drug use
• Abuse of alcohol and caffeine

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging; Monitoring, Physiologic; Blood Specimen Collection; Blood Pressure Determination; Body Temperature; Surveys and Questionnaires; Pregnancy Tests

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Cardiovascular; Physical Examination; Vital Signs; Physiological Phenomena; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diagnostic Techniques, Obstetrical and Gynecological

Study Officials

• Eric Achten, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Clement, Msc

CONTACT

9 332 1330; patricia.clement@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: October 3, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

BE (1)