Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Condition(s) studied

Investigational drug(s) / intervention(s)

Samples collection (whole blood, urine, vaginal and cervical cells): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota. — Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
  To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.

Trial sites (1)

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