Does exposure to different menstrual products affect the vaginal environment?
Nicolas Tessandier, Ilkay Başak Uysal, Baptiste Elie...
https://pubmed.ncbi.nlm.nih.gov/36057782Actively Recruiting
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
ID07199998
Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota
Led by Centre National de la Recherche Scientifique, France · Updated on 2026-04-09
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre National de la Recherche Scientifique, France
Lead Sponsor
I
Institut Alfred Fournier
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore how different menstrual protection products, such as tampons, menstrual cups, and external pads, may impact vaginal health. The study focuses on understanding their effects on vaginal microbiota, immune responses, and the recurrence of gynecological conditions like bacterial vaginosis, mycosis, and dysbiosis. It addresses a public health concern due to limited research on women's menstrual and sexual health and the minimal regulatory oversight of internal menstrual products. Participants will be grouped based on their main menstrual protection method: menstrual cup users, tampon users, and external sanitary pad users. Biological samples including vaginal, cervical, urinary, and blood will be collected during clinical visits. These samples will be analyzed for differences in vaginal microbiota composition, immune responses through cytokine profiling and flow cytometry, and exposure to environmental pollutants found in urine. Women taking part will undergo gynecological exams and provide various biological samples that will be stored and analyzed for microbial, immune, and toxicological markers. The primary outcome is to determine how internal menstrual product use affects vaginal microbiota. Secondary outcomes include comparing immune responses and pollutant levels in urine. The study involves ongoing monitoring of participants' health and sample collection, with analyses conducted within 24 months after collection.
CONDITIONS
Brief Title
Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
Who Can Participate
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures and be available for the study duration
- Female aged 18 to 49 years
- Generally in good health based on medical history
- Covered by the national health insurance system
- Willing to sign a written informed consent form
- Has experienced menstruation prior to the study
- No vaginal sexual intercourse within 72 hours before study visit
- Had at least 6 menstrual periods in the past 12 months
You will not qualify if you...
- HIV infection
- Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior
- History of hormonal disorders or irregular menstrual cycles
- Metrorrhagia (abnormal bleeding)
- Pregnancy or breastfeeding
- Family members or close relatives of the clinical or scientific team
- Treatment for chronic inflammatory diseases or conditions within past 12 months
- Participation in another ongoing clinical trial
- Antibiotic treatment within 4 weeks prior to study
- Refusal to be informed of detected abnormalities
- Use of both tampons and menstrual cups indistinctly
- Never had vaginal penetrative intercourse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Single visit during study participation
Participants undergo a clinical visit where biological samples including blood, urine, vaginal, and cervical cells are collected for analysis of vaginal microbiota, immune responses, and exposure to environmental pollutants.
1 clinical visit (in-person)
Trial Site Locations
Total: 1 location
1
Institut Alfred Fournier
Paris, Île-de-France Region, France, 75014
Actively Recruiting
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Research Team
S
Samuel Alizon, Dr
C
Clinical team
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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