NCT07779447|Active Not Recruiting
Cardiovascular Impact of the Menstrual Cycle and Contraception - Longitudinal Evaluation
CICCLE
Effets of the Hormonal Cycle and Contraception on Cardiovascular System and Sport Performance
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CICCLE
Effets of the Hormonal Cycle and Contraception on Cardiovascular System and Sport Performance
Sponsor study identifier
observational
60
1 country
1
Study Start
February 1, 2024
Actual (reported)Primary Completion
March 31, 2026
Actual (reported)Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The present study aims to understand the impact of the hormonal cycle and contraceptive pill on cardiac and vascular function, as well as aerobic capacity among women. A well-structured study, minimizing confounding factors, will be conducted with repeated measurements at specific phases of the menstrual cycle to assess the influence of endogenous sexual hormone changes on cardiovascular function and aerobic capacity. The hypothesis is that cyclic changes in oestrogen and progesterone, and to a lesser extent hormonal contraception, could have a subtle but non-negligible influence on cardiovascular function at rest and during exercise. To test this, 60 healthy young women (18-35 years old) (eumenorrheic, nulliparous, free of any gynaecological/cardiovascular/neurological/osteomuscular/respiratory pathologies, non-smokers, non-obese, not professional athletes), with (30 women) and without hormonal contraception (30 women), will undergo cardiovascular assessments at rest and during exercise (including HRV (heart rate variability) analysis at rest, during effort and after maximal effort, baroreflex and metaboreflex, echocardiography at rest and during effort, blood sample analysis for inflammatory and cardiovascular factors) at the following phases of one identical hormonal cycle: early follicular (menstruation), late follicular (ovulation), and mid-luteal phases. Assessment of the menstrual phases (menstruation, late follicular phase (FP), and luteal phase (LP)) will be performed using three distinct approaches: monitoring cycle symptoms, daily urinary hormone concentration measurement, and blood hormone analysis during each visit.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2024
Actual (reported)June 11, 2025
Actual (reported)March 31, 2026
Actual (reported)August 21, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Maximal Oxygen Uptake (VO₂max) Assessed by Cardiopulmonary Exercise Testing
Aerobic capacity will be assessed by maximal oxygen uptake (VO₂max) obtained during an incremental cardiopulmonary exercise test (CPET). VO₂max values will be compared across menstrual cycle phases and between naturally cycling women and women using hormonal contraception.
From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).
Right ventricular-pulmonary artery coupling across menstrual cycle phases and hormonal contraception assessed by echocardiography
From enrollment to completion of study assessments (approximately 3 months, including 2 months of menstrual cycle and luteinizing hormone tracking followed by 1 month of laboratory visits).
Women with spontaneous regular natural cycles
Women taking monophasic contraceptive pill
60 healthy women : 30 healthy youg (18-35 ans) female with hormonal contraception (pill), and 30 healthy women without hormonal contraception will be recruted, matched for age, sex, body mass index (BMI) and physical activity level. All women will have regular cycles with ovulation assessed (between 26 and 34 days with maximum 2 to 3 days of difference between cycles) be eumenorrheic, nulliparous, free of any gynaecological/cardiovascular/neurologic/osteomuscular/respiratory pathologies, non-smoker, non-obese (BMI between 18.5 and 25) and drug-free.
Université Libre de Bruxelles - Campus Erasme - Faculté des Sciences de la Motricité Humaine - Laboratoire de Physiologie Cardiorespiratoire, Exercice et Nutrition
Anderlecht, Brussels Capital, 1070, Belgium
serum and plasma
Vitalie Faoro, Professor
Université Libre de Bruxelles
60 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2025
First Posted
August 21, 2026
Study Start
February 1, 2024
Actual (reported)Resting Energy Expenditure Assessed by Indirect Calorimetry
From enrollment to completion of study assessments (approximately 3 months).
Spontaneous cardiac sensitivity at rest
From enrollment to completion of study assessments (approximately 3 months).
Cardiac baroreflex sensitivity during dynamic exercise
From enrollment to completion of study assessments (approximately 3 months).
Resting heart rate variability assessed by electrocardiography
From enrollment to completion of study assessments (approximately 3 months).
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2026
Actual (reported)Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
It is not necessary in our study
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