OvulationFemiClockNCT07687823
FemiClock: Non-invasive Tools Development (Salivary and Hair Progesterone) for Ovulation Detection in Heathy Women With Regular Menstrual Cycles Without Contraception.
A study testing Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch, Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires and Hormonal blood assessment in people with Ovulation and Female Fertility, run by University Hospital, Strasbourg, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation, Female Fertility, Menstrual Cycle
- What is being tested?
- Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch, Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires and Hormonal blood assessment
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Ovulation, Female Fertility, Menstrual Cycle
- Being tested
- Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch, Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires, Hormonal blood assessment
- Keywords
- Progesterone, Circadian Clocks, Ovulation Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: Non-invasive ovulation biomarker assessment - SmartwatchDevice
Continuous monitoring of physiological and activity parameters using a connected smartwatch during three consecutive menstrual cycles.
Diagnostic Test: Non-invasive ovulation biomarker assessment - QuestionnairesBehavioural
Completion of questionnaires regarding menstrual cycle characteristics, lifestyle, sleep, diet and reproductive health.
Hormonal blood assessmentDiagnostic test
Blood sampling for luteinizing hormone (LH) and progesterone measurements used as reference markers of ovulation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy women undergoing non-invasive ovulation assessment | Experimental | 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. Receives: Device: Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch; Behavioral: Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires; Diagnostic Test: Hormonal blood assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women in whom salivary and hair samples are successfully collected to assess the technical feasibility of progesterone measurements in saliva and hair.
Measured: Over three consecutive menstrual cycles (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvulationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault BAHOUGNE BAHOUGNE, Dr, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687823
- Sponsor's protocol ID
- 8839
- Other IDs
- 2024-A01058-39
- Acronym
- FemiClock
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FemiClock: Modeling Daily and Reproductive Parameters in Women: Proof of Concept and Feasibility of Analytical Methods for the Study of Female Fertility.
- ClinicalTrials.gov ID
- NCT07687823
- Acronym / sponsor ID
- FemiClock / 8839
- Conditions
- Ovulation, Female Fertility, Menstrual Cycle
- Keywords
- Progesterone, Circadian Clocks, Ovulation Detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy women undergoing non-invasive ovulation assessment | Experimental | Device: Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch, Behavioral: Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires, Diagnostic Test: Hormonal blood assessmentHealthy 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Non-invasive ovulation biomarker assessment - SmartwatchContinuous monitoring of physiological and activity parameters using a connected smartwatch during three consecutive menstrual cycles. | Device | Healthy women undergoing non-invasive ovulation assessment |
| Diagnostic Test: Non-invasive ovulation biomarker assessment - QuestionnairesCompletion of questionnaires regarding menstrual cycle characteristics, lifestyle, sleep, diet and reproductive health. | Behavioural | Healthy women undergoing non-invasive ovulation assessment |
| Hormonal blood assessmentBlood sampling for luteinizing hormone (LH) and progesterone measurements used as reference markers of ovulation. | Diagnostic test | Healthy women undergoing non-invasive ovulation assessment |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibault BAHOUGNE BAHOUGNE, Dr principal investigator
Hôpitaux Universitaires de Strasbourg
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch, Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires and Hormonal blood assessment in people with Ovulation and Female Fertility, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène SOAVELO (33.3.88.11.65.59, helene.soavelo@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.