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)

ISRCTN	ISRCTN32882895
DOI	https://doi.org/10.1186/ISRCTN32882895
Secondary identifying numbers	N/A

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 04/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr I J G Ketel
Scientific

VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 0041
Email	ijg.ketel@vumc.nl

Study information

Study design	Non-randomised clinical trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Scientific title
Study acronym	MCycle
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	Microcirculatory function measured in three phases of the cycle (early and late follicular, and luteal).
Secondary outcome measures	Blood pressure.
Overall study start date	23/10/2006
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	16
Key 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
Key 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
Date of first enrolment	23/10/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (The Netherlands)
Hospital/treatment centre

Department of Reproductive Medicine
Postbus 7057
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.nl/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

Institute for Cardiovascular Research of the Vrije University of Amsterdam (ICaR-VU) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan