Understanding Socio-ecological Variation in Menstrual Cycles to Advance Female Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Mean Luteal Phase Salivary Progesterone
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Environment 1a
Women with low socio-economic status in rural areas
干预措施: Self-saliva sampling (Other)
Environment 1a
Women with low socio-economic status in rural areas
干预措施: Self-collection of dried blood spots (Other)
Environment 1a
Women with low socio-economic status in rural areas
干预措施: Wearing the connected ring (Other)
Environment 1a
Women with low socio-economic status in rural areas
干预措施: Ovulation test (Other)
Environment 1b
Women with high socio-economic status in rural areas
干预措施: Self-saliva sampling (Other)
Environment 1b
Women with high socio-economic status in rural areas
干预措施: Self-collection of dried blood spots (Other)
Environment 1b
Women with high socio-economic status in rural areas
干预措施: Wearing the connected ring (Other)
Environment 1b
Women with high socio-economic status in rural areas
干预措施: Ovulation test (Other)
Environment 2a
Women with low socio-economic status in urban areas
干预措施: Self-saliva sampling (Other)
Environment 2a
Women with low socio-economic status in urban areas
干预措施: Self-collection of dried blood spots (Other)
Environment 2a
Women with low socio-economic status in urban areas
干预措施: Wearing the connected ring (Other)
Environment 2a
Women with low socio-economic status in urban areas
干预措施: Ovulation test (Other)
Environment 2b
Women with high socio-economic status in urban areas
干预措施: Self-saliva sampling (Other)
Environment 2b
Women with high socio-economic status in urban areas
干预措施: Self-collection of dried blood spots (Other)
Environment 2b
Women with high socio-economic status in urban areas
干预措施: Wearing the connected ring (Other)
Environment 2b
Women with high socio-economic status in urban areas
干预措施: Ovulation test (Other)
结局指标
主要结局
Mean Luteal Phase Salivary Progesterone
时间窗: 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
Mean Luteal Phase Salivary Progesterone
时间窗: 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
次要结局
- Estradiol levels(One menstrual cycle (up to 45 days))
- The length of cycles(Day 0)
- Cycle regularity(Day 0 and the day before the first day of the next cycle)
- Duration of the period(Day 0 and the last day of menstruation (up to 45 days))
- Flow abundance(Day 0 and the last day of menstruation (up to 45 days))
- Score Higham(Day 0 and the last day of menstruation (up to Day 45))
- Progesterone levels(One menstrual cycle (up to 45 days))
- Body temperature(One menstrual cycle (up to 45 days))
- Intermenstrual bleeding(One menstrual cycle (up to 45 days))
- Pain during menstruation(Day 2)
- 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)
- Cycle regularity(Day 0 and the day before the first day of the next cycle)
- Duration of the period(Day 0 and the last day of menstruation (up to 45 days))
- Flow abundance(Day 0 and the last day of menstruation (up to 45 days))
- Score Higham(Day 0 and the last day of menstruation (up to Day 45))
- Ovulation test(Day 7 to positive test (up to Day 45) or until Day 39 if ovulation is not detected)
- Body temperature(One menstrual cycle (up to 45 days))
- Length of the luteal phase(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(One menstrual cycle (up to 45 days))
- Premenstrual symptoms Intensity(Day 12 and 12 days after ovulation (or Day 44 if ovulation is not detected))
- Pain during menstruation(Day 2)