Contact information
Type
Scientific
Primary contact
Dr I J G Ketel
ORCID ID
Contact details
VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0041
ijg.ketel@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MCycle
Study hypothesis
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Non-randomised clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Small vascular function, arterial compliance
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Microcirculatory function measured in three phases of the cycle (early and late follicular, and luteal).
Secondary outcome measures
Blood pressure.
Overall trial start date
23/10/2006
Overall trial end date
01/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
16
Participant exclusion criteria
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
Recruitment start date
23/10/2006
Recruitment end date
01/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Center (The Netherlands)
Sponsor details
Department of Reproductive Medicine
Postbus 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Institute for Cardiovascular Research of the Vrije University of Amsterdam (ICaR-VU) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary