Understanding Cycles to Improve Women's Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-39
SponsorUniversity Hospital, Montpellier
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Self-saliva sampling
- Self-collection of dried blood spots
- Wearing the connected ring
- Ovulation test
Treatment groups
320 Participants
are divided into 4 treatment groupsSponsors and collaborators
University Hospital, Montpellier
Lead sponsor
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
Source ClinicalTrials.gov