Understanding Cycles to Improve Women's Health
Understanding Socio-ecological Variation in Menstrual Cycles to Advance Female Health
University Hospital, Montpellier
320 participants
Sep 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Woman of childbearing age (18-39 years)
- Woman not using hormonal contraception for at least 6 months
- Woman with semi-regular menstrual cycles between 21 and 45 days inclusive
- Woman with no known history of infertility
- Woman working in the same environment (urban/rural) as her place of residence
- Knowledge of the dates of periods over the last 3 cycles
- Woman who has a freezer at -20°C
Exclusion Criteria14
- Diagnosis by a physician of one or more of the following comorbidities: Polycystic ovarian syndrome (PCOS), Endometriosis, Adenomyosis, Diabetes or thyroid disease, Hormone-dependent gynecological cancers (breast, endometrium, ovaries), Coagulation diseases (von Willebrand), Chronic liver failure, chronic renal failure, heart disease, autoimmune disease, Autism, Diagnosis and/or treatment for a psychiatric illness
- Chronic exposure to cocaine, amphetamine/methamphetamine, morphine or ecstasy within 30 days prior to inclusion
- Chronic exposure to THC within 7 days prior to inclusion.
- Person who is not comfortable with self-sampling (hematophobia or other)
- No access to a smartphone
- No possibility of wearing a connected ring for at least 60 days 22h/24h
- Pregnant or breastfeeding woman
- Woman who gave birth or breastfed in the 2 months before the study
- Person who moved less than 2 years before the study (does not concern participants who moved in the same environment (rural or urban, less than 20 km)
- Person unable to read French
- Failure to obtain informed consent
- Person not benefiting from a national health insurance scheme
- Person under legal protection, guardianship or curatorship
- Person participating in other research involving the human person
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Interventions
Self-saliva samples are taken every day from D1 inclusive over 1 consecutive cycle, to measure progesterone (P4) and estradiol (E2) concentrations.
Self-blood sampling is done 5 times during the cycle to measure protéine C-Réactive (CRP) concentrations.
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.
An ovulation test (Ovulatest®) is carried out from day 7 until a test is positive, or until day 39 if ovulation is not detected
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07037082