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.
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure to environmental pollutants. The project consists of two complementary components: \- Epidemiological Study: An online survey will be conducted with 1,500 to 1,800 participants, collecting detailed information on the usage habits of menstrual protection products (such as menstrual cups, tampons, and external pads), as well as self-reported symptoms and history of urogenital infections. This dataset will allow for large-scale correlation analyses between menstrual hygiene practices and women's health indicators. \- Clinical Study: A total of approximately 300 women will be recruited and divided into three groups based on their primary menstrual protection method: Group 1: Menstrual cup users Group 2: Tampon users Group 3: External sanitary pad users All clinical participants will undergo a gynecological examination and provide vaginal, cervical, urinary, and blood samples. These biological samples will be used for in-depth analysis across three main areas: * Microbiology: studying the vaginal microbiota composition and identifying infectious or dysbiotic profiles. * Immunology: assessing local immune responses, including cytokine levels and antibody titers. * Toxicology: measuring exposure to potential environmental pollutants through menstrual product use. Sequencing, immune profiling, pollutant quantification, and cytobacteriological screening will be conducted to evaluate potential differences between groups. These analyses aim to provide a better understanding of how menstrual protection methods may influence vaginal ecosystem balance, immune activity, and overall urogenital health.
Study Type
OBSERVATIONAL
Enrollment
300
During 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.
Institut Alfred Fournier
Paris, Île-de-France Region, France
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.
Time frame: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
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.
Time frame: Samples for this purpose will be prepared for preservation immediately after collection. After preparation, they will be stored at -80°C and subsequently shipped for the analyses.
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.
Time frame: Urine samples will be stored at -80°C and analysed within 24 months after collection.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.