Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
NCT ID: NCT07199998
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2025-10-01
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tampon-only user
This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months.
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.
Cups-only user
This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months.
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.
External-only user
This group includes participants who have not used any internal menstrual products in the past six months, relying instead on external protection such as sanitary pads.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female, aged 18 to 49 years.
* In general good health, as determined by medical history.
* Covered by the national health insurance system.
* Willing to sign a written informed consent form.
* Has already experienced menstruation prior to the start of the study.
* No vaginal sexual intercourse within 72 hours before the study visit.
* Has had at least 6 menstrual periods in the past 12 months.
Exclusion Criteria
* Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
* History of hormonal disorders or menstrual cycle irregularities.
* Metrorrhagia.
* Pregnancy or breastfeeding.
* Family members or close relatives of the clinical or scientific team.
* Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.
* Participation in an ongoing clinical trial.
* Receiving or having received antibiotic treatment within the 4 weeks prior to the study.
* Refusal to be informed in case of detected abnormalities.
* Indistinct use of both tampons and menstrual cups.
* Never having had vaginal penetrative intercourse.
18 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Alfred Fournier
UNKNOWN
Centre National de la Recherche Scientifique, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Samuel Alizon
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samuel Alizon, Doctor in Biology
Role: PRINCIPAL_INVESTIGATOR
Centre National de la Recherche Scientifique, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Alfred Fournier
Paris, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Tessandier N, Uysal IB, Elie B, Selinger C, Bernat C, Boue V, Grasset S, Groc S, Rahmoun M, Reyne B, Bender N, Bonneau M, Graf C, Tribout V, Foulongne V, Ravel J, Waterboer T, Hirtz C, Bravo IG, Reynes J, Segondy M, Murall CL, Boulle N, Kamiya T, Alizon S. Does exposure to different menstrual products affect the vaginal environment? Mol Ecol. 2023 May;32(10):2592-2601. doi: 10.1111/mec.16678. Epub 2022 Oct 4.
Related Links
Access external resources that provide additional context or updates about the study.
French webpage of the study cohort
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-A00597-40
Identifier Type: -
Identifier Source: org_study_id