An interventional study of Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch and Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires in Ovulation, Female Fertility and Menstrual Cycle, sponsored by University Hospital, Strasbourg, France. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic
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.
University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
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Exclusion Criteria:
Exposure to potential endocrine disruptors will not be specifically assessed due to their high environmental prevalence and the complexity of their detection.
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.
Device: Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch · Behavioral: Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires · Diagnostic Test: Hormonal blood assessment
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.
Proportion of women in whom salivary and hair samples are successfully collected to assess the technical feasibility of progesterone measurements in saliva and hair.
Time frame: Over three consecutive menstrual cycles (approximately 3 months)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France