Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
CUPS2
Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota
1 other identifier
observational
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
September 30, 2025
CompletedStudy Start
First participant enrolled
April 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 9, 2026
April 1, 2026
11 months
August 20, 2025
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
Secondary Outcomes (2)
Comparison of the vaginal immune response of users and non-users of internal menstrual products
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.
Urine samples will be stored at -80°C and analysed within 24 months after collection.
Other Outcomes (1)
Associations between the type of menstrual hygiene product used and sexually transmitted infections (STIs)
Statistical analyses will be performed after the last participant follow-up. They will be based on inclusion questionnaires. The time frame to evaluate the incidence of STIs will be the 12 months before inclusion.
Study Arms (3)
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.
Cups-only user
This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months.
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.
Interventions
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
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.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Alfred Fournier
Paris, Île-de-France Region, 75014, France
Related Publications (1)
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.
PMID: 36057782BACKGROUND
Related Links
Biospecimen
Vaginal, cervical, urinary, and whole blood samples will be collected, each containing human and/or microbial DNA in varying proportions: vaginal and cervical samples provide both host and microbiota DNA, whole blood contains primarily human leukocyte DNA, while urine offers a mix of host epithelial and microbial DNA, though in lower quantity.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Alizon, Doctor in Biology
Centre National de la Recherche Scientifique, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2025
First Posted
September 30, 2025
Study Start
April 7, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04