An observational study in Woman of Reproductive Age and Socioeconomic Factors, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University Hospital, Montpellier · Observational
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.
Introduction:
Menstrual health is an important indicator of women's overall health, but the biological and environmental factors influencing the menstrual cycle are still poorly understood. The C-HEALTH study explores how social and ecological conditions - such as pollution, stress, socio-economic status, and living environment - affect hormonal patterns and menstrual health in women living in the Occitanie region (France).
Aim:
The primary objective is to compare luteal phase progesterone levels among women from different socio-economic backgrounds living in either rural or urban areas in the Occitanie region.
The secondary objectives are:
Methods:
To meet the objectives of this research, 80 women aged 18-45 living in Occitanie (France) will be enrolled in each socioeconomic group at each location (4 groups: low-income urban, high-income urban, low-income rural, high-income rural; total n=320).
After the inclusion visit (visit 1) and the training visit for self-sampling (visit 2), participants will collect their biological samples and data during one observed menstrual cycle, with a follow-up visit on day 7 of the cycle (visit 3), and will complete their participation with the collection of biological samples at home (visit 4).
Biological samples (saliva and dried blood spots) will be collected no later than 30 days after the end of the collection period.
The exposome matrix will be inferred using postcode and will include data from an air pollution database (Environment Data Management System - EDMS) linked primarily to traffic, industry, stationary fuel burners, forest fires and solid fuel combustion, comfort parameters (temperature, humidity), UV, pollen count, green, grey and blue spaces, vegetation, Shannon biodiversity index, noise, water quality (pesticides, heavy metals)
At the end of this study:
3,438 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 320 is above the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women were initially recruted from medical and paramedical practices, hospitals, clinics, pharmacies and medical advisors from the different environments studied in Occitanie, then in a second time via social networks (Facebook and Snapchat) and local newspapers (e.g. Midi Libre) in the event of recruitment difficulties.
Exclusion Criteria:
Women with low socio-economic status in rural areas
Other: Self-saliva sampling · Other: Self-collection of dried blood spots · Other: Wearing the connected ring · Other: Ovulation test
Women with high socio-economic status in rural areas
Other: Self-saliva sampling · Other: Self-collection of dried blood spots · Other: Wearing the connected ring · Other: Ovulation test
Women with low socio-economic status in urban areas
Other: Self-saliva sampling · Other: Self-collection of dried blood spots · Other: Wearing the connected ring · Other: Ovulation test
Women with high socio-economic status in urban areas
Other: Self-saliva sampling · Other: Self-collection of dried blood spots · Other: Wearing the connected ring · Other: Ovulation test
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
Mean Luteal Phase Salivary Progesterone
Mean salivary progesterone concentration (pg/mL) measured during the luteal phase - from the day after ovulation (Day of Ovulation, Jov) to the end of the menstrual cycle, or from day 32 to 45 if ovulation is not detected. The outcome is used to compare hormonal levels between women of low vs. high socioeconomic status living in rural (Environment 1) or urban (Environment 2) areas in the Occitanie region
Time frame: One menstrual cycle (up to 45 days)
Progesterone levels
Progesterone levels (pg/ml) will be measured in saliva every day of the observed cycle. Averages will be calculated over 7 periods of the cycle: * Follicular Average * Follicular Peak Average * Luteal Average * Luteal Peak Average * Preovulatory Average\* * Periovulatory Average\* * Postovulatory Week 1 Average\* * Postovulatory Week 2 Average\* * Postovulatory Week 3 Average\* (\* for ovulatory cycles only)
Time frame: One menstrual cycle (up to 45 days)
Estradiol levels
Estradiol levels (pg/ml) will be measured in saliva every day of the observed cycle. Averages will be calculated during 7 periods of the cycle: * Follicular Average * Follicular Peak Average * Luteal Average * Luteal Peak Average * Preovulatory Average\* * Periovulatory Average\* * Postovulatory Week 1 Average\* * Postovulatory Week 2 Average\* * Postovulatory Week 3 Average\* (\* for ovulatory cycles only)
Time frame: One menstrual cycle (up to 45 days)
Protéine C Réactive (CRP) levels
CRP levels (mg/L) will be measured in the blood at 5 points during the observed cycle: * Day 2 (D2) * Day 7 (D7) * Day of ovulation (Dov) or Day 32 (D32=D45-13) if ovulation is not detected * at the Luteal Peak on Dov+7 or Day 39 (D39=D45-6) if ovulation is not detected * in the premenstrual phase on Dov+12 or Day 44 (D44=D45-1) if ovulation is not detected * Difference in CRP will be measured between D2 and Dov+7, or between D2 and D39 if ovulation is not detected
Time frame: Day 2, Day 7, Day of ovulation (or Day 32 if ovulation is not detected), 7 days after ovulation (or Day 39 if ovulation is not detected), 12 days after ovulation (or Day 44 if ovulation is not detected)
The length of cycles
The length (in days) of the 3 cycles preceding the observed cycle
Time frame: Day 0
Period frequency
Period frequency in the observed cycle (calculated as the length of a cycle: Duration between the first day of the observed cycle (D0) and the day before the first day of the next cycle). * Amenorrhea: no bleeding * Infrequent: \> 38 days * Normal: 24 to 38 days * Frequent: \< 24 days
Time frame: Day 0 and the day before the next cycle
Cycle regularity
Cycle regularity over the observed cycle and the three previous cycles: Difference (in days) between the longest and shortest cycle over four continuous cycles. * Normal or regular: difference ≤ 7-9 days) * Irregular: difference ≥ 10 days)
Time frame: Day 0 and the day before the first day of the next cycle
Duration of the period
The duration of the period in the observed cycle (in days). * Amenorrhea: 0 days * Normal: ≤ 8 days * Prolonged: \> 8 days
Time frame: Day 0 and the last day of menstruation (up to 45 days)
Flow abundance
Flow abundance (heavy/light) Heavy periods are defined as the need to change a sanitary napkin or tampon every 1 or 2 hours.
Time frame: Day 0 and the last day of menstruation (up to 45 days)
Score Higham
Score Higham is an objective assessment of menstrual blood loss based on the number of sanitary pads used and clots passed, to classify periods are light, normal or heavy. Score interpretation: * 100 points: blood loss of at least 80 mL, indicating menorrhagia. * 150 points: potential indication for surgical intervention in menometrorrhagia.
Time frame: Day 0 and the last day of menstruation (up to Day 45)
Ovulation test
Ovulatest® ovulation test performed from Day 7 until a positive test is obtained, or until Day 39 (D39=Day 45-6) if ovulation is not detected. Ovulation is considered the day following the positive test.
Time frame: Day 7 to positive test (up to Day 45) or until Day 39 if ovulation is not detected
Body temperature
Body temperature will be recorded on a smart ring throughout the observed cycle. Ovulation will be detected by an increase of at least 0.3°C by the smart ring.
Time frame: One menstrual cycle (up to 45 days)
Length of the luteal phase
Length of the luteal phase (in days), defined as the number of days between Dov (inclusive, measured by the first positive Ovulatest®) and the last day of the cycle. * ≤ 10 days: short luteal phase * \> 10 days: normal luteal phase (Practice Committees of the American Society for Reproductive Medicine and the Society for Reproductive Endocrinology and Infertility, 2021)
Time frame: First Day of ovulation and the day before the first day of the following cycle (up to Day 45), only if ovulation is detected
Intermenstrual bleeding
Presence of intermenstrual bleeding in the observed cycle (yes/no, and if yes, specify cycle day/date)
Time frame: One menstrual cycle (up to 45 days)
Premenstrual symptoms Intensity
Premenstrual symptoms intensity will be assessed over the observed cycle: * On Day 12 for the period between Days 6 and 12 (mid-follicular phase), * On Day 12 (Days 6 to 12) or Day 44 (Days 38 to 44) if ovulation is not detected. 16 symptoms (sweet cravings, increased appetite, mood swings/anxiety, fatigue, breast tenderness, weight gain, bloating, constipation or diarrhea, abdominal pain, headaches, sleep problems, inattention/distraction, hot flashes, decreased libido, oily hair, skin irritation) will be rated on a Likert scale from 1 to 5 (1=No symptoms; 2=Mild symptoms; 3=Moderate symptoms; 4=Severe symptoms; 5=Very severe symptoms).
Time frame: Day 12 and 12 days after ovulation (or Day 44 if ovulation is not detected)
Pain during menstruation
Pain during menstruation will be assessed on Day 2 of the observed cycle using a visual numeric scale (VNS) from 0 to 10.
Time frame: Day 2
Plan to share: Yes — De-identified individual participant data (IPD) will be made available to other researchers upon reasonable request, following publication of the main study results. Data sharing will be subject to approval by the study steering committee and may require a data-sharing agreement to ensure compliance with GDPR and ethical guidelines
Supporting information: Study protocol, Sap, Icf, Analytic code
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University Hospital, Montpellier