Understanding Cycles to Improve Women's Health

NCT07037082 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2025-11-28

No results posted yet for this study

Summary

Introduction:

The C-HEALTH study investigates how environmental and socio-economic conditions affect women's menstrual cycles and reproductive health.

Aim:

To compare progesterone levels during the luteal phase among women from different socio-economic backgrounds living in rural and urban areas in southern France.

Methods:

This is a prospective observational study involving 320 healthy women of reproductive age.

* Hormones (progesterone, estradiol) will be measured daily in saliva.
* Inflammation (Protéine C Réactive: CRP) will be measured five times per cycle via blood drops.
* Participants will wear a smart ring to monitor body temperature and activity.
* Daily symptoms and lifestyle data will be collected.
* Environmental exposures (pollution, stress, living conditions) will be assessed and linked to menstrual health outcomes.

Conditions

  • Woman of Reproductive Age
  • Socioeconomic Factors

Interventions

OTHER

Self-saliva sampling

Self-saliva samples are taken every day from D1 inclusive over 1 consecutive cycle, to measure progesterone (P4) and estradiol (E2) concentrations.

OTHER

Self-collection of dried blood spots

Self-blood sampling is done 5 times during the cycle to measure protéine C-Réactive (CRP) concentrations.

OTHER

Wearing the connected ring

A connected ring is worn every day of the observed cycle, while maintaining lifestyle habits, to measure daily body temperature, assess heart rate variability and resting heart rate, evaluate physical activity and energy expenditure, assess stress level, and evaluate sleep quality.

OTHER

Ovulation test

An ovulation test (Ovulatest®) is carried out from day 7 until a test is positive, or until day 39 if ovulation is not detected

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Centre National de la Recherche Scientifique, France

    collaborator OTHER
  • Institute of Evolutionary Science of Montpellier

    collaborator UNKNOWN
  • Université Montpellier

    collaborator OTHER
  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Alexandra ALVERGNE, PhD · Institute of Evolutionary Science of Montpellier (ISEM)

  • Noémie RANISAVLJEVIC, MD · University Montpellier hospital

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2029-07-01
Completion
2029-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037082 on ClinicalTrials.gov