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ISRCTN
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ISRCTN32882895
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ClinicalTrials.gov identifier
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Public title
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The variations in small vascular function and arterial compliance during the menstrual cycle in young healthy women (De cyclus afhankelijke variatie in de microcirculatie bij jonge gezonde ovulerende vrouwen)
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Scientific title
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Acronym
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MCycle
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Serial number at source
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N/A
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Study hypothesis
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It has been suggested in literature that insulin sensitivity and determinants of the blood pressure vary according to the past ovulation cycle. Since microcirculation plays a large role in the transport and supply of insulin to the muscle fibres, it can be assumed that the microcirculatory function cycle will be dependent on the ovulation cycle. Indeed from literature it has been suggested that this is true, however another group of researchers found no cycle dependent pattern. Moreover in the Vrije University the most unique method has been developed to measure the microcirculation (capillary microscope) and this measuring has never been examined in women in their ovulation cycle. The results of this research are very important for the interpretation of cardiovascular events in women during their ovulation cycle.
Hypothesis:
Microcirculatory function is cycle dependent in healthy ovulating women.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Non-randomised clinical trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Small vascular function, arterial compliance
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Participants - inclusion criteria
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1. Healthy as judged by history and physical examination
2. Regular ovulatory menstrual cycles between 21 - 35 days (proven by biphasic basal temperature curve [BTC] or midluteal progesterone more than 10 nmol/l)
3. Aged 18 to 35 years
4. No medication including oral conceptive or hormonal intra-uterine device (IUD) for at least three months
5. Informed consent
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Participants - exclusion criteria
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1. Cardiovascular disease (hypertension [more than 160/90 mmHg], stroke, coronary artery disease, peripheral vascular disease, heart failure)
2. Diabetes mellitus (according to American Diabetes Association [ADA] criteria)
3. Smoking for the last three months
4. Alcohol use more than 4 units/day
5. Pregnancy
6. Diseases that influence reproductive hormone status
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Anticipated start date
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23/10/2006
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Anticipated end date
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01/04/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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16
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Interventions
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Microcirculation measured by means of:
1. Microscopic examination of the nail bed (assessment of the refill after temporary occlusion of the finger)
2. Ionthophoresis with acetylcholine (ACH) (endothelium dependent) and sodiumnitroprusside (SNP) (endothelium independent vasodilatation)
3. Blood pressure
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Primary outcome measure(s)
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Microcirculatory function measured in three phases of the cycle (early and late follicular, and luteal).
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Secondary outcome measure(s)
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Blood pressure.
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Sources of funding
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Institute for Cardiovascular Research of the Vrije University of Amsterdam (ICaR-VU) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
I J G
Ketel
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Address
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VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
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City/town
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Amsterdam
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Zip/Postcode
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1007 MB
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Country
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Netherlands
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Tel
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+31 (0)20 444 0041
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Fax
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+31 (0)20 444 0045
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Email
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ijg.ketel@vumc.nl
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Sponsor
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VU University Medical Center (The Netherlands)
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Address
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Department of Reproductive Medicine
Postbus 7057
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City/town
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Amsterdam
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Zip/Postcode
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1007 MB
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Country
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Netherlands
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Sponsor website:
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http://www.vumc.nl/
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Date applied
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28/12/2006
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Last edited
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04/03/2008
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Date ISRCTN assigned
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28/12/2006
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