Understanding Cycles to Improve Women's Health

NCT07037082 | Recruiting

• 1 other identifier: RECHMPL23_0352
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Menstrual Cycle; Exposome; Hormones; Inflammation; Rural/Urban; Socioeconomic status; Pollution; Ovulation

Outcome Measures

Primary Outcomes (1)

• 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

  One menstrual cycle (up to 45 days)

Secondary Outcomes (15)

• Progesterone levels

  One menstrual cycle (up to 45 days)

• Estradiol levels

  One menstrual cycle (up to 45 days)

• Protéine C Réactive (CRP) levels

  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

  Day 0

• Period frequency

  Day 0 and the day before the next cycle

Study Arms (4)

Environment 1a

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

Environment 1b

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

Environment 2a

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

Environment 2b

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

Interventions

Self-saliva sampling OTHER

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

Environment 1a; Environment 1b; Environment 2a; Environment 2b

Self-collection of dried blood spots OTHER

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

Environment 1a; Environment 1b; Environment 2a; Environment 2b

Wearing the connected ring OTHER

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.

Environment 1a; Environment 1b; Environment 2a; Environment 2b

Ovulation test OTHER

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

Environment 1a; Environment 1b; Environment 2a; Environment 2b

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• National Research Agency, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• Institute of Evolutionary Science of Montpellier: collaborator
• Université Montpellier: collaborator

Study Sites (1)

Institute of Evolutionary Science of Montpellier

Montpellier, 34090, France

RECRUITING

Related Publications (26)

• 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.

  PMID: 17079600 BACKGROUND

• Male V. COVID-19 vaccination and menstruation. Science. 2022 Nov 18;378(6621):704-706. doi: 10.1126/science.ade1051. Epub 2022 Nov 17.

  PMID: 36395209 BACKGROUND

• Wang 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.

  PMID: 32998909 BACKGROUND

• Jasienska 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.

  PMID: 28792413 BACKGROUND

• Merklinger-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.

  PMID: 28726748 BACKGROUND

• Vitzthum 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.

  PMID: 19890865 BACKGROUND

• Jasienska 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.

  PMID: 15368604 BACKGROUND

• Lorenz 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.

  PMID: 27865788 BACKGROUND

• Lorenz 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.

  PMID: 26394125 BACKGROUND

• Alvergne 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.

  PMID: 29778270 BACKGROUND

• Munro 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.

  PMID: 30609040 BACKGROUND

• Vitzthum 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.

  PMID: 33022128 BACKGROUND

• Gregory 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.

  PMID: 36837884 BACKGROUND

• McDade 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.

  PMID: 14981035 BACKGROUND

• McDade 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.

  PMID: 18232218 BACKGROUND

• McDade TW. Development and validation of assay protocols for use with dried blood spot samples. Am J Hum Biol. 2014 Jan-Feb;26(1):1-9. doi: 10.1002/ajhb.22463. Epub 2013 Oct 15.

  PMID: 24130128 BACKGROUND

• Fontana R, Della Torre S. The Deep Correlation between Energy Metabolism and Reproduction: A View on the Effects of Nutrition for Women Fertility. Nutrients. 2016 Feb 11;8(2):87. doi: 10.3390/nu8020087.

  PMID: 26875986 BACKGROUND

• Vitzthum VJ, Bentley GR, Spielvogel H, Caceres E, Thornburg J, Jones L, Shore S, Hodges KR, Chatterton RT. Salivary progesterone levels and rate of ovulation are significantly lower in poorer than in better-off urban-dwelling Bolivian women. Hum Reprod. 2002 Jul;17(7):1906-13. doi: 10.1093/humrep/17.7.1906.

  PMID: 12093859 BACKGROUND

• Tshomo T, Gurung MS, Shah S, Gil-Cuesta J, Maes P, Wangdi R, Tobden J. Menstrual Hygiene Management-Knowledge, Attitudes, and Practices Among Female College Students in Bhutan. Front Reprod Health. 2021 Aug 27;3:703978. doi: 10.3389/frph.2021.703978. eCollection 2021.

  PMID: 36303967 BACKGROUND

• Li K, Urteaga I, Wiggins CH, Druet A, Shea A, Vitzthum VJ, Elhadad N. Characterizing physiological and symptomatic variation in menstrual cycles using self-tracked mobile-health data. NPJ Digit Med. 2020 May 26;3:79. doi: 10.1038/s41746-020-0269-8. eCollection 2020.

  PMID: 32509976 BACKGROUND

• Lenton EA, Landgren BM, Sexton L, Harper R. Normal variation in the length of the follicular phase of the menstrual cycle: effect of chronological age. Br J Obstet Gynaecol. 1984 Jul;91(7):681-4. doi: 10.1111/j.1471-0528.1984.tb04830.x.

  PMID: 6743609 BACKGROUND

• Windham GC, Elkin EP, Swan SH, Waller KO, Fenster L. Cigarette smoking and effects on menstrual function. Obstet Gynecol. 1999 Jan;93(1):59-65. doi: 10.1016/s0029-7844(98)00317-2.

  PMID: 9916957 BACKGROUND

• Jukic AM, Weinberg CR, Baird DD, Wilcox AJ. Lifestyle and reproductive factors associated with follicular phase length. J Womens Health (Larchmt). 2007 Nov;16(9):1340-7. doi: 10.1089/jwh.2007.0354.

  PMID: 18001191 BACKGROUND

• Kato I, Toniolo P, Koenig KL, Shore RE, Zeleniuch-Jacquotte A, Akhmedkhanov A, Riboli E. Epidemiologic correlates with menstrual cycle length in middle aged women. Eur J Epidemiol. 1999 Oct;15(9):809-14. doi: 10.1023/a:1007669430686.

  PMID: 10608360 BACKGROUND

• Fenster L, Quale C, Waller K, Windham GC, Elkin EP, Benowitz N, Swan SH. Caffeine consumption and menstrual function. Am J Epidemiol. 1999 Mar 15;149(6):550-7. doi: 10.1093/oxfordjournals.aje.a009851.

  PMID: 10084244 BACKGROUND

• Cole SK, Billewicz WZ, Thomson AM. Sources of variation in menstrual blood loss. J Obstet Gynaecol Br Commonw. 1971 Oct;78(10):933-9. doi: 10.1111/j.1471-0528.1971.tb00208.x. No abstract available.

  PMID: 5111902 BACKGROUND

Related Links

• Ellison, P. T. Reproductive Ecology and Human Evolution. (Aldine de Gruyter, 2001)
• New survey shows 'deep-rooted' taboos around periods. (2022)
• Children's Hospital of Philadelphia. Period Poverty: The Public Health Crisis We Don't Talk About. (2021)
• Valvaikar, K. \& Shah, H. An urban-rural comparison of menstrual pattern and menstrual problems among school-going girls. Int J Med Sci Public Health. 5, 2086. (2016)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva and dried blood spot

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra ALVERGNE, PhD

  Institute of Evolutionary Science of Montpellier (ISEM)

  STUDY DIRECTOR

• Noémie RANISAVLJEVIC, MD

  University Montpellier hospital

  STUDY CHAIR

Central Study Contacts

Alexandra ALVERGNE, PhD

CONTACT

+33467144966; alexandra.alvergne@umontpellier.fr

Charlotte FAURIE, MD

CONTACT

charlotte.faurie@umontpellier.fr

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: * Start Date: 6 months after publication of primary results * End Date: 5 years after data availability begins
• Access Criteria: Qualified researchers with a scientifically and ethically sound proposal will be eligible to access the de-identified individual participant data (IPD) and supporting documents, including the study protocol, statistical analysis plan, informed consent form, and analytic code

Locations

FR (1)