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| Name | Class |
|---|---|
| Institut Alfred Fournier | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cups-only user | This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samples collection (whole blood, urine, vaginal and cervical cells) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Associations between the type of menstrual hygiene product used and sexually transmitted infections (STIs) | Retrospective epidemiological analyses will be performed using statistical modelling on the questionnaires filled in at the inclusion visit. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Alizon, Dr | Contact | +33(4)144271667 | samuel.alizon@cnrs.fr | |
| Clinical team | Contact | cups2@college-de-france.fr |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Alizon, Doctor in Biology | Centre National de la Recherche Scientifique, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Alfred Fournier | Recruiting | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36057782 | Background | 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. |
| Label | URL |
|---|---|
| French webpage of the study cohort | View source |
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Participants who wish to be informed about the results of the research will receive information in French about the scientific publications via a newsletter or posts on social media (e.g. mastodon).
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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.
|
| 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. | Urine samples will be stored at -80°C and analysed within 24 months after collection. |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D016585 | Vaginosis, Bacterial |
| D009181 | Mycoses |
| D000091642 | Urogenital Diseases |
| D064806 | Dysbiosis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D014554 | Urination |
| ID | Term |
|---|---|
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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