NCT07199998

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Centre National de la Recherche Scientifique, France · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Sexual Transmitted Disease
• Vaginosis, Bacterial
• Mycosis
• Urogenital Disease
• HPV
• Dysbiosis
• Toxic Shock Syndrome
• Menstrual Cup

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2026-04-07
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-09-30
• Last updated: 2026-04-09

Locations

1 site across 1 country: France