FemiClock: Non-invasive Tools Development (Salivary and Hair Progesterone) for Ovulation Detectio… (NCT07687823) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
FemiClock: Non-invasive Tools Development (Salivary and Hair Progesterone) for Ovulation Detection in Heathy Women With Regular Menstrual Cycles Without Contraception.
30 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of women in whom salivary and hair samples are successfully collected to assess the technical feasibility of progesterone measurements in saliva and hair.
Timeframe: Over three consecutive menstrual cycles (approximately 3 months)