FemiClock: Non-invasive Tools Development (Salivary and Hair Progesterone) for Ovulation Detection in Heathy Women With Regular Menstrual Cycles Without Contraception.

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.

Conditions

• Ovulation
• Female Fertility
• Menstrual Cycle

Interventions

DEVICE

Diagnostic Test: Non-invasive ovulation biomarker assessment - Smartwatch

Continuous monitoring of physiological and activity parameters using a connected smartwatch during three consecutive menstrual cycles.

BEHAVIORAL

Diagnostic Test: Non-invasive ovulation biomarker assessment - Questionnaires

Completion of questionnaires regarding menstrual cycle characteristics, lifestyle, sleep, diet and reproductive health.

DIAGNOSTIC_TEST

Hormonal blood assessment

Blood sampling for luteinizing hormone (LH) and progesterone measurements used as reference markers of ovulation.

Sponsors & Collaborators

• University Hospital, Strasbourg, France

  lead OTHER

Principal Investigators

• Thibault BAHOUGNE BAHOUGNE, Dr · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-03-01

Completion

2028-03-01