NCT07037082 Understanding Cycles to Improve Women's Health
| NCT ID | NCT07037082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Woman of Reproductive Age |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2025-09-01 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Alexandra ALVERGNE, PhD
STUDY DIRECTOR
Institute of Evolutionary Science of Montpellier (ISEM)
Frequently Asked Questions
Who can join the NCT07037082 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Woman of Reproductive Age. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07037082 currently recruiting?
Yes, NCT07037082 is actively recruiting participants. Contact the research team at alexandra.alvergne@umontpellier.fr for enrollment information.
Where is the NCT07037082 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07037082 clinical trial?
NCT07037082 is sponsored by University Hospital, Montpellier. The principal investigator is Alexandra ALVERGNE, PhD at Institute of Evolutionary Science of Montpellier (ISEM). The trial plans to enroll 320 participants.