Condition category
Circulatory System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/

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

Publication citations

Additional files

Editorial Notes