The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.
This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
Willingness to comply with all study procedures and availability for the duration of the study.
Female, aged 18 to 49 years.
In general good health, as determined by medical history.
Covered by the national health insurance system.
HIV infection.
Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
History of hormonal disorders or menstrual cycle irregularities.
Metrorrhagia.
The study population includes individuals of the female sex, aged 18 to 49 years, who have already experienced at least one menstrual period and meet the inclusion criteria. Participants are residents of the Île-de-France region and are recruited either through the Alfred Fournier Institute or via an online epidemiological survey.
Cohort
Prospective
Samples collection (whole blood, urine, vaginal and cervical cells)
Other interventionDuring the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts.
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.
Comparison of the vaginal immune response of users and non-users of internal menstrual products
Description of the cellular composition from vaginal and cervical samples (CyTOF technique) and measurement of vaginal cytokines. Since this is a cross-sectional study, all the measures are made at inclusion, i.e. at baseline.
Effect of the type of internal menstrual protections on the presence of pollutants in urine.
Quantification of parabens and other pollutants in urine samples or other samples.
Associations between the type of menstrual hygiene product used and sexually transmitted infections (STIs)
Retrospective epidemiological analyses will be performed using statistical modelling on the questionnaires filled in at the inclusion visit.
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Centre National de la Recherche Scientifique, France
Lead sponsor
Institut Alfred Fournier
Collaborator
