Woman of Reproductive AgeC-HEALTHNCT07037082
Understanding Cycles to Improve Women's Health
An observational study of Woman of Reproductive Age and Socioeconomic Factors, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Woman of Reproductive Age, Socioeconomic Factors
- What is being tested?
- Self-saliva sampling, Self-collection of dried blood spots and Wearing the connected ring
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte FAURIE, MD contact
France1 site, 1 recruiting
- Recruiting
Institute of Evolutionary Science of Montpellier
Montpellier, 34090
Alexandra ALVERGNE, PhD, +33467144966, alexandra.alvergne@umontpellier.fr
Charlotte FAURIE, MD
About this study
Official title: Understanding Socio-ecological Variation in Menstrual Cycles to Advance Female Health
Introduction:
The C-HEALTH study investigates how environmental and socio-economic conditions affect women's menstrual cycles and reproductive health.
Read more
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.
Read the detailed description
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:
- To compare, according to the women's environment: levels of sex hormones (progesterone and estradiol) throughout a menstrual cycle, levels of an inflammation marker (C-reactive protein) throughout a menstrual cycle, and the description of the menstrual cycle (characteristics, possible abnormalities such as pain, abnormal bleeding, etc.).
- To identify environmental factors associated with potential biological and menstrual cycle abnormalities.
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:
- Saliva samples will be analyzed using ELISA tests to measure steroid levels.
- Dried blood spot samples will be analyzed using immunoenzymatic assays to measure CRP levels, using the ELISA technique.
- The exposome will be analyzed using classical statistics, clustering/PCA (Principal Component Analysis) to assess exposure profiles, and EnWAS will be used to untangle independent associations between exposure variables and menstrual cycle parameters. A series of minimally adjusted univariate analyses will be performed and exposures significant at the false discovery rate will be retained in the cluster analysis. Within each cluster, a multivariable analysis will be performed to reduce the number of variables of interest. This will allow us to identify exposome factors independently associated with menstrual health.
- Conditions
- Woman of Reproductive Age, Socioeconomic Factors
- Being tested
- Self-saliva sampling, Self-collection of dried blood spots, Wearing the connected ring, Ovulation test
- Keywords
- Menstrual Cycle, Exposome, Hormones, Inflammation, Rural/Urban, Socioeconomic status, Pollution, Ovulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-saliva samplingOther
Self-saliva samples are taken every day from D1 inclusive over 1 consecutive cycle, to measure progesterone (P4) and estradiol (E2) concentrations.
Self-collection of dried blood spotsOther
Self-blood sampling is done 5 times during the cycle to measure protéine C-Réactive (CRP) concentrations.
Wearing the connected ringOther
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.
Ovulation testOther
An ovulation test (Ovulatest®) is carried out from day 7 until a test is positive, or until day 39 if ovulation is not detected
| Study group | Role | What they receive |
|---|---|---|
| Environment 1a | Women with low socio-economic status in rural areas Receives: Other: Self-saliva sampling; Other: Self-collection of dried blood spots; Other: Wearing the connected ring; Other: Ovulation test | |
| Environment 1b | Women with high socio-economic status in rural areas Receives: Other: Self-saliva sampling; Other: Self-collection of dried blood spots; Other: Wearing the connected ring; Other: Ovulation test | |
| Environment 2a | Women with low socio-economic status in urban areas Receives: Other: Self-saliva sampling; Other: Self-collection of dried blood spots; Other: Wearing the connected ring; Other: Ovulation test | |
| Environment 2b | Women with high socio-economic status in urban areas Receives: Other: Self-saliva sampling; Other: Self-collection of dried blood spots; Other: Wearing the connected ring; Other: Ovulation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One menstrual cycle (up to 45 days)
Secondary outcomes (15)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Woman of Reproductive AgeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Institute of Evolutionary Science of Montpellier, Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Alexandra ALVERGNE, PhD, Study director, Institute of Evolutionary Science of Montpellier (ISEM)Noémie RANISAVLJEVIC, MD, Study chair, University Montpellier hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037082
- Sponsor's protocol ID
- RECHMPL23_0352
- Acronym
- C-HEALTH
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
American Academy of Pediatrics Committee on Adolescence; American College of Obstetricians and Gynecologists Committee on Adolescent Health Care; Diaz A, Laufer MR, Breech LL. Menstruation in girls and adolescents: using the menstrual cycle as a vital sign. Pediatrics. 2006 Nov;118(5):2245-50. doi: 10.1542/peds.2006-2481.
PubMed 17079600Male V. COVID-19 vaccination and menstruation. Science. 2022 Nov 18;378(6621):704-706. doi: 10.1126/science.ade1051. Epub 2022 Nov 17.
PubMed 36395209Wang YX, Arvizu M, Rich-Edwards JW, Stuart JJ, Manson JE, Missmer SA, Pan A, Chavarro JE. Menstrual cycle regularity and length across the reproductive lifespan and risk of premature mortality: prospective cohort study. BMJ. 2020 Sep 30;371:m3464. doi: 10.1136/bmj.m3464.
PubMed 32998909Jasienska G, Bribiescas RG, Furberg AS, Helle S, Nunez-de la Mora A. Human reproduction and health: an evolutionary perspective. Lancet. 2017 Jul 29;390(10093):510-520. doi: 10.1016/S0140-6736(17)30573-1. Epub 2017 Jul 27.
PubMed 28792413Merklinger-Gruchala A, Jasienska G, Kapiszewska M. Effect of Air Pollution on Menstrual Cycle Length-A Prognostic Factor of Women's Reproductive Health. Int J Environ Res Public Health. 2017 Jul 20;14(7):816. doi: 10.3390/ijerph14070816.
PubMed 28726748Vitzthum VJ. The ecology and evolutionary endocrinology of reproduction in the human female. Am J Phys Anthropol. 2009;140 Suppl 49:95-136. doi: 10.1002/ajpa.21195.
PubMed 19890865Jasienska G, Ellison PT. Energetic factors and seasonal changes in ovarian function in women from rural Poland. Am J Hum Biol. 2004 Sep-Oct;16(5):563-80. doi: 10.1002/ajhb.20063.
PubMed 15368604Lorenz TK, Heiman JR, Demas GE. Testosterone and immune-reproductive tradeoffs in healthy women. Horm Behav. 2017 Feb;88:122-130. doi: 10.1016/j.yhbeh.2016.11.009. Epub 2016 Nov 17.
PubMed 27865788Lorenz TK, Demas GE, Heiman JR. Interaction of menstrual cycle phase and sexual activity predicts mucosal and systemic humoral immunity in healthy women. Physiol Behav. 2015 Dec 1;152(Pt A):92-8. doi: 10.1016/j.physbeh.2015.09.018. Epub 2015 Sep 21.
PubMed 26394125Alvergne A, Hogqvist Tabor V. Is Female Health Cyclical? Evolutionary Perspectives on Menstruation. Trends Ecol Evol. 2018 Jun;33(6):399-414. doi: 10.1016/j.tree.2018.03.006. Epub 2018 May 16.
PubMed 29778270Munro MG, Critchley HOD, Fraser IS; FIGO Menstrual Disorders Committee. Corrigendum to "The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions" [Int J Gynecol Obstet 143(2018) 393-408.]. Int J Gynaecol Obstet. 2019 Feb;144(2):237. doi: 10.1002/ijgo.12709. Epub 2018 Nov 27. No abstract available.
PubMed 30609040Vitzthum VJ. Field methods and strategies for assessing female reproductive functioning. Am J Hum Biol. 2021 Sep;33(5):e23513. doi: 10.1002/ajhb.23513. Epub 2020 Oct 6.
PubMed 33022128Gregory S, Denham SG, Lee P, Simpson JP, Homer NZM. Using LC-MS/MS to Determine Salivary Steroid Reference Intervals in a European Older Adult Population. Metabolites. 2023 Feb 13;13(2):265. doi: 10.3390/metabo13020265.
PubMed 36837884McDade TW, Burhop J, Dohnal J. High-sensitivity enzyme immunoassay for C-reactive protein in dried blood spots. Clin Chem. 2004 Mar;50(3):652-4. doi: 10.1373/clinchem.2003.029488. No abstract available.
PubMed 14981035McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.
PubMed 18232218
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Socio-ecological Variation in Menstrual Cycles to Advance Female Health
- ClinicalTrials.gov ID
- NCT07037082
- Acronym / sponsor ID
- C-HEALTH / RECHMPL23_0352
- Conditions
- Woman of Reproductive Age, Socioeconomic Factors
- Keywords
- Menstrual Cycle, Exposome, Hormones, Inflammation, Rural/Urban, Socioeconomic status, Pollution, Ovulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National Research Agency, France, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de la Recherche Scientifique, France, Institute of Evolutionary Science of Montpellier, Université Montpellier
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To compare, according to the women's environment: levels of sex hormones (progesterone and estradiol) throughout a menstrual cycle, levels of an inflammation marker (C-reactive protein) throughout a menstrual cycle, and the description of the menstrual cycle (characteristics, possible abnormalities such as pain, abnormal bleeding, etc.).
- To identify environmental factors associated with potential biological and menstrual cycle abnormalities.
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:
- Saliva samples will be analyzed using ELISA tests to measure steroid levels.
- Dried blood spot samples will be analyzed using immunoenzymatic assays to measure CRP levels, using the ELISA technique.
- The exposome will be analyzed using classical statistics, clustering/PCA (Principal Component Analysis) to assess exposure profiles, and EnWAS will be used to untangle independent associations between exposure variables and menstrual cycle parameters. A series of minimally adjusted univariate analyses will be performed and exposures significant at the false discovery rate will be retained in the cluster analysis. Within each cluster, a multivariable analysis will be performed to reduce the number of variables of interest. This will allow us to identify exposome factors independently associated with menstrual health.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Environment 1a | – | Other: Self-saliva sampling, Other: Self-collection of dried blood spots, Other: Wearing the connected ring, Other: Ovulation testWomen with low socio-economic status in rural areas |
| Environment 1b | – | Other: Self-saliva sampling, Other: Self-collection of dried blood spots, Other: Wearing the connected ring, Other: Ovulation testWomen with high socio-economic status in rural areas |
| Environment 2a | – | Other: Self-saliva sampling, Other: Self-collection of dried blood spots, Other: Wearing the connected ring, Other: Ovulation testWomen with low socio-economic status in urban areas |
| Environment 2b | – | Other: Self-saliva sampling, Other: Self-collection of dried blood spots, Other: Wearing the connected ring, Other: Ovulation testWomen with high socio-economic status in urban areas |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-saliva samplingSelf-saliva samples are taken every day from D1 inclusive over 1 consecutive cycle, to measure progesterone (P4) and estradiol (E2) concentrations. | Other | Environment 1a, Environment 1b, Environment 2a, Environment 2b |
| Self-collection of dried blood spotsSelf-blood sampling is done 5 times during the cycle to measure protéine C-Réactive (CRP) concentrations. | Other | Environment 1a, Environment 1b, Environment 2a, Environment 2b |
| Wearing the connected ringA 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 | Environment 1a, Environment 1b, Environment 2a, Environment 2b |
| Ovulation testAn ovulation test (Ovulatest®) is carried out from day 7 until a test is positive, or until day 39 if ovulation is not detected | Other | Environment 1a, Environment 1b, Environment 2a, Environment 2b |
Primary outcome
Mean Luteal Phase Salivary Progesterone
Time frame: One menstrual cycle (up to 45 days)
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
15 secondary outcomes
Progesterone levels
Time frame: One menstrual cycle (up to 45 days)
Estradiol levels
Time frame: One menstrual cycle (up to 45 days)
Protéine C Réactive (CRP) levels
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
Time frame: Day 0
Period frequency
Time frame: Day 0 and the day before the next cycle
Cycle regularity
Time frame: Day 0 and the day before the first day of the next cycle
Duration of the period
Time frame: Day 0 and the last day of menstruation (up to 45 days)
Flow abundance
Time frame: Day 0 and the last day of menstruation (up to 45 days)
Score Higham
Time frame: Day 0 and the last day of menstruation (up to Day 45)
Ovulation test
Time frame: Day 7 to positive test (up to Day 45) or until Day 39 if ovulation is not detected
Body temperature
Time frame: One menstrual cycle (up to 45 days)
Length of the luteal phase
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
Time frame: One menstrual cycle (up to 45 days)
Premenstrual symptoms Intensity
Time frame: Day 12 and 12 days after ovulation (or Day 44 if ovulation is not detected)
Pain during menstruation
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 17079600American Academy of Pediatrics Committee on Adolescence; American College of Obstetricians and Gynecologists Committee on Adolescent Health Care; Diaz A, Laufer MR, Breech LL. Menstruation in girls and adolescents: using the menstrual cycle as a vital sign. Pediatrics. 2006 Nov;118(5):2245-50. doi: 10.1542/peds.2006-2481.
- Background: PubMed 36395209Male V. COVID-19 vaccination and menstruation. Science. 2022 Nov 18;378(6621):704-706. doi: 10.1126/science.ade1051. Epub 2022 Nov 17.
- Background: PubMed 32998909Wang YX, Arvizu M, Rich-Edwards JW, Stuart JJ, Manson JE, Missmer SA, Pan A, Chavarro JE. Menstrual cycle regularity and length across the reproductive lifespan and risk of premature mortality: prospective cohort study. BMJ. 2020 Sep 30;371:m3464. doi: 10.1136/bmj.m3464.
- Background: PubMed 28792413Jasienska G, Bribiescas RG, Furberg AS, Helle S, Nunez-de la Mora A. Human reproduction and health: an evolutionary perspective. Lancet. 2017 Jul 29;390(10093):510-520. doi: 10.1016/S0140-6736(17)30573-1. Epub 2017 Jul 27.
- Background: PubMed 28726748Merklinger-Gruchala A, Jasienska G, Kapiszewska M. Effect of Air Pollution on Menstrual Cycle Length-A Prognostic Factor of Women's Reproductive Health. Int J Environ Res Public Health. 2017 Jul 20;14(7):816. doi: 10.3390/ijerph14070816.
- Background: PubMed 19890865Vitzthum VJ. The ecology and evolutionary endocrinology of reproduction in the human female. Am J Phys Anthropol. 2009;140 Suppl 49:95-136. doi: 10.1002/ajpa.21195.
- Background: PubMed 15368604Jasienska G, Ellison PT. Energetic factors and seasonal changes in ovarian function in women from rural Poland. Am J Hum Biol. 2004 Sep-Oct;16(5):563-80. doi: 10.1002/ajhb.20063.
- Background: PubMed 27865788Lorenz TK, Heiman JR, Demas GE. Testosterone and immune-reproductive tradeoffs in healthy women. Horm Behav. 2017 Feb;88:122-130. doi: 10.1016/j.yhbeh.2016.11.009. Epub 2016 Nov 17.
- Background: PubMed 26394125Lorenz TK, Demas GE, Heiman JR. Interaction of menstrual cycle phase and sexual activity predicts mucosal and systemic humoral immunity in healthy women. Physiol Behav. 2015 Dec 1;152(Pt A):92-8. doi: 10.1016/j.physbeh.2015.09.018. Epub 2015 Sep 21.
- Background: PubMed 29778270Alvergne A, Hogqvist Tabor V. Is Female Health Cyclical? Evolutionary Perspectives on Menstruation. Trends Ecol Evol. 2018 Jun;33(6):399-414. doi: 10.1016/j.tree.2018.03.006. Epub 2018 May 16.
- Background: PubMed 30609040Munro MG, Critchley HOD, Fraser IS; FIGO Menstrual Disorders Committee. Corrigendum to "The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions" [Int J Gynecol Obstet 143(2018) 393-408.]. Int J Gynaecol Obstet. 2019 Feb;144(2):237. doi: 10.1002/ijgo.12709. Epub 2018 Nov 27. No abstract available.
- Background: PubMed 33022128Vitzthum VJ. Field methods and strategies for assessing female reproductive functioning. Am J Hum Biol. 2021 Sep;33(5):e23513. doi: 10.1002/ajhb.23513. Epub 2020 Oct 6.
- Ellison, P. T. Reproductive Ecology and Human Evolution. (Aldine de Gruyter, 2001)Link provided by the sponsor.
- New survey shows 'deep-rooted' taboos around periods. (2022)Link provided by the sponsor.
- Children's Hospital of Philadelphia. Period Poverty: The Public Health Crisis We Don't Talk About. (2021)Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte FAURIE, MD contact
Alexandra ALVERGNE, PhD study director
Institute of Evolutionary Science of Montpellier (ISEM)
Noémie RANISAVLJEVIC, MD study chair
University Montpellier hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Woman of Reproductive Age and Socioeconomic Factors, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra ALVERGNE, PhD (+33467144966, alexandra.alvergne@umontpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Luteal Phase Salivary Progesterone (time frame: One menstrual cycle (up to 45 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07037082, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.