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
This trial accepts healthy volunteersQualifiers
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 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.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Self-saliva sampling
Other interventionSelf-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 spots
Other interventionSelf-blood sampling is done 5 times during the cycle to measure protéine C-Réactive (CRP) concentrations.
Wearing the connected ring
Other interventionA 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 test
Other interventionAn ovulation test (Ovulatest®) is carried out from day 7 until a test is positive, or until day 39 if ovulation is not detected
Treatment groups
320 Participants
are divided into 4 treatment groupsGroup A: Environment 1a4 interventions
Group B: Environment 1b4 interventions
Group C: Environment 2a4 interventions
Group D: Environment 2b4 interventions
Trial outcomes
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
Time frame
One menstrual cycle (up to 45 days)Secondary outcomes
1
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)2
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)3
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)4
The length of cycles
The length (in days) of the 3 cycles preceding the observed cycle
Time frame
Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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