Cardiovascular Impact of the Menstrual Cycle and Contraception - Longitudinal Evaluation

NCT07779447 | Active Not Recruiting

• 1 other identifier: ciccle2425
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women Under Hormonal Contraception (Pill) or Without Hormonal Contraception

Keywords

hormonal cycle; hormonal contraception; aerobic performance; stress echocardiography; cardiovascular system; sport performance; HRV; metaboreflex; baroreflex

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• 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).

• 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).

Study Arms (2)

no hormonal contraception

Women with spontaneous regular natural cycles

under contraception - monophasic pill

Women taking monophasic contraceptive pill

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: We measure spontaneous natural endogenous female hormones across a hormonal cycle, therefore only females are recruted in our study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Female, aged 18 to 35 years.
• Healthy participant.
• Either;
• Current user of hormonal oral contraception for at least 3 months prior to enrollment; or
• Naturally cycling woman not using hormonal contraception.
• Regular menstrual cycles between 26 and 34 days, with no more than 2-3 days variation between consecutive cycles.
• Evidence of ovulation during the menstrual cycle monitoring period.
• Nulliparous.
• Body mass index (BMI) between 18.5 and 25.0 kg/m².
• Able and willing to comply with all study procedures and visits.

You may not qualify if:

• Current smoker or use of nicotine-containing products.
• Pregnancy or breastfeeding.
• History or presence of gynecological disorders.
• History or presence of cardiovascular disease.
• History or presence of neurological disease.
• History or presence of respiratory disease.
• History or presence of musculoskeletal disorders that may affect exercise performance.
• Obesity (BMI \>25.0 kg/m²).
• Use of medications known to affect cardiovascular, respiratory, autonomic, or hormonal function.
• Inability or unwillingness to abstain from alcohol and caffeine for 72 hours before each experimental session.

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

Study Officials

• Vitalie Faoro, Professor

  Université Libre de Bruxelles

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc (HMS), PhD Student, Assistant

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: August 21, 2026
• Study Start: February 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)