FemiClock: Non-invasive Tools Development (Salivary and Hair Progesterone) for Ovulation Detection in Heathy Women With Regular Menstrual Cycles Without Contraception. (FemiClock)
FemiClock: Modeling Daily and Reproductive Parameters in Women: Proof of Concept and Feasibility of Analytical Methods for the Study of Female Fertility.
Currently, the gold standard to confirm ovulation is measuring LH and/or progesterone in blood.
However, because confirmation requires a blood sample, this approach is not suitable for epidemiological studies evaluating the impact of various factors on ovulation.
Additionally, in cases of irregular menstrual cycles, there is additional difficulty in determining when the blood sample should be taken.
Our objective is the development of non-invasive markers of ovulation (salivary and hair progesterone) in women with regular menstrual cycles over a period of 3 menstrual cycles. Our hypothesis is that there is a correlation between ovulation detection, using the "gold standard" i.e. detection of the pre-ovulatory LH surge associated with an increase in progesterone during the mid-luteal phase, and the mean level of hair progesterone measured between 2 menstrual cycles.
Various studies have shown that, to be functional, the female reproductive axis requires an intact circadian system characterized by the existence of biological clocks called "clock genes" which are expressed in 24-hour cycles. In rodent, mutations in these "clock genes" lead to irregular menstrual cycles and alterations in the preovulatory LH surge. A quantitative measurement (using quantitative RT-PCR) of clock gene expression in the oral cavity will be performed.
Since the reproductive system is also under the influence of locomotor activity and diet, all of these parameters will also be analyzed using participants' smartphones and connected smartwatches.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hélène SOAVELO
- Номер телефона: 33.3.88.11.65.59
- Электронная почта: helene.soavelo@chru-strasbourg.fr
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Women aged 18 to 40 years, with a body mass index (BMI) between 19.0 and 29.9 kg/m². (Women with low or high BMI were excluded due to extensive literature showing a negative impact of extreme BMI values on the hypothalamic-pituitary-ovarian axis.)
- Women not using hormonal contraception (or using a non-hormonal copper intrauterine device), or who discontinued hormonal contraception more than 3 months prior to enrollment and do not plan to resume contraception during the 3 study menstrual cycles.
- Women with regular menstrual cycles between 25 and 35 days, with cycle length variability (difference between shortest and longest cycle) strictly less than 7 days.
- Women owning a smartphone (to enable collection and transmission of data recorded by a study-provided smartwatch).
- Exclusive daytime workers (no night or shift work).
- Hair length greater than 5 cm from root to tip, and willingness to provide a hair sample.
- Individuals affiliated with a national health insurance system or equivalent coverage.
- Individuals able to understand the study objectives and risks and willing to provide written informed consent (dated and signed).
Exclusion Criteria:
- Known fertility disorder.
- Night work and/or shift work within the 6 months prior to enrollment (between 9:00 p.m. and 6:00 a.m.).
- Untreated endocrine disorders or gynecological conditions that may affect menstrual cycles and/or ovulation, including clinical hyperandrogenism.
- History of cancer within the past 5 years.
- History of severe psychiatric disorder.
- Current use of hormonal treatment or synthetic steroid therapy.
- Self-reported pregnancy or breastfeeding within the past 3 months.
- Participants currently in an exclusion period following participation in a previous clinical study.
- Individuals under legal protection (guardianship, curatorship, or legal safeguard).
- Inability to provide informed consent (e.g., emergency situation, cognitive or comprehension difficulties).
- Desire for pregnancy within the 3 months following enrollment. The occurrence of pregnancy will not be considered an exclusion criterion; data collected during the menstrual cycle preceding pregnancy may still be analyzed, as it reflects a fertile cycle.
Exposure to potential endocrine disruptors will not be specifically assessed due to their high environmental prevalence and the complexity of their detection.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Healthy women undergoing non-invasive ovulation assessment
Healthy women with regular menstrual cycles will undergo non-invasive ovulation assessment over three consecutive menstrual cycles, including saliva, urine, hair and oral mucosal sample collection, blood sampling for reference hormonal measurements, completion of study questionnaires, and continuous monitoring using a smartwatch and smartphone application.
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Continuous monitoring of physiological and activity parameters using a connected smartwatch during three consecutive menstrual cycles.
Completion of questionnaires regarding menstrual cycle characteristics, lifestyle, sleep, diet and reproductive health.
Blood sampling for luteinizing hormone (LH) and progesterone measurements used as reference markers of ovulation.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Proportion of women in whom salivary and hair samples are successfully collected to assess the technical feasibility of progesterone measurements in saliva and hair.
Временное ограничение: Over three consecutive menstrual cycles (approximately 3 months)
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Over three consecutive menstrual cycles (approximately 3 months)
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Соавторы и исследователи
Следователи
- Главный следователь: Thibault BAHOUGNE BAHOUGNE, Dr, Hopitaux Universitaires de Strasbourg
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 8839
- 2024-A01058-39 (Другой идентификатор: N° IDRCB)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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