Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch
DeviceContinuous monitoring of physiological and activity parameters using a connected smartwatch during three consecutive menstrual cycles.
NCT Number: NCT07687823
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.
Trial opening soon.
Get Notified18 year–40 year
Female
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exposure to potential endocrine disruptors will not be specifically assessed due to their high environmental prevalence and the complexity of their detection.
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.
Time frame: Over three consecutive menstrual cycles (approximately 3 months)
Contact information is provided by the study sponsor or research team.
University Hospital, Strasbourg, France
Other
FemiClock: Modeling Daily and Reproductive Parameters in Women: Proof of Concept and Feasibility of Analytical Methods for the Study of Female Fertility.
Acronym: FemiClock
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07248046
Artifical Intelligence, Body Temperature
Ottawa, Ontario, Canada
View Trial DetailsNCT06142097
Menstrual Cycle, Menstruation
San Francisco, California, United States
View Trial DetailsNCT04196595
Adnexal Diseases, Cysts
Boston, Massachusetts, United States
View Trial DetailsNCT07466199
Assisted Reproductive Treatments, Hormonal Response
Lisbon, Portugal
View Trial Details