Questionnaire

    Kindly provide the order number* of the purchased kit
    *Your order number can be found on the confirmation email you received when purchasing your kit.

    Kindly tick the option that refers to you:
    I am…

    Consent to Personal Data (Mandatory)

    i. I have been fully informed about the vaginal microbiome test (and any additional related test), including its purpose, procedure, limitations, costs, and the implications of the results.
    ii. I acknowledge that the test results are not a substitute for a medical diagnosis and that The BioArte does not take responsibility for the use of the results by me or my clinician and any consequences thereof.
    iii. I confirm that the personal and medical information I have provided is accurate and truthful. I understand that the clinical team may contact me for additional information, which may be used for result interpretation purposes. I agree that the test report may be forwarded to my clinician for appropriate advice.
    iv. I agree to provide a biological sample and consent to its shipping to The BioArte facilities for testing and analysis.
    v. I consent to the collection, storage, and processing of my personal data, including health-related information. I understand that my data will be used solely for the purposes of conducting the vaginal microbiome test and providing me with the results. I am aware that my identifiable data will not be shared with third parties without my explicit consent, except as required by law.
    vi. I consent to receiving the test report via email to the address provided in the below contact information.

    Consent for Research Purposes (Optional)

    The aim of our research is to explore the role of the vaginal microbiota in women's health and its impact on medical treatments.
    The vaginal microbiome plays a vital role in maintaining reproductive and general health. Imbalances in the microbiome have been linked to various conditions such as infections, inflammation, and fertility challenges. We are interested in understanding how differences in the vaginal microbiome may influence health outcomes.
    To investigate this, we will analyze vaginal microbiota samples from participants. Your participation involves providing a vaginal swab sample, which will be analyzed for this purpose.
    The insights gained from this study could be crucial in improving our understanding of the vaginal microbiome and developing better, more personalized medical treatments in the future.
    Your involvement is entirely voluntary, and you can withdraw at any time without affecting your current or future medical care. We assure you that all the data collected will be kept confidential and used solely for research purposes.
    By signing this consent form, you agree to provide a vaginal sample for our study and acknowledge that you have been informed about the study's purpose, procedures, and your rights as a participant.
    Thank you for your cooperation and contribution to this important research.

    I acknowledge that my Personal (Health) Data and remaining sample could contribute to further research, development, and enhancement of diagnostic techniques and potential therapeutic remedies. I consent to The BioArte's storage, once pseudonymized, of:

    • My Personal (Health) Data and analytical results.

    • Both original and processed sample

    and that it will be kept by The BioArte for a minimum period of 10 years.

    The company will use this data, along with the remaining samples that have been pseudonymized, for scientific research (both internally and externally) as well as for commercial research in the field related to the human microbiome. The aim is to gain a better understanding of the microbiome's role in an individual's overall health and susceptibility to diseases, as well as their potential response to treatments. Consent can be revoked at any time as explained below.
    Public and private healthcare institutions, bio-medical companies worldwide, can be granted access to the patient’s pseudonymized data for research purposes, with the relevant guarantees adopted to ensure legitimacy of the data transfer (especially if the recipient is in a non-EEA country).
    Please visit www.thebioarte.com or contact [email protected] for updated information on the research projects in which your pseudonymized data may be used.

    Please visit Data Privacy to consult our data privacy policy.

    HAVING READ AND UNDERSTOOD THE INFORMATION ABOVE, I CONFIRM THAT:
    i. I have read and understood the indication, purpose, characteristics, scope, procedure, success rate, complications, limitations, and economic cost of this test, and have had the opportunity to ask questions and any questions that I had were answered fully and to my satisfaction. I have also been given information on the implications of the test results, any possible follow-up, and where applicable, any further tests that might be required. I am aware that clinical and technical staff will be at my disposal for any questions or additional counseling that I may require once the results of the test are known.
    ii. I understand that the results of this test are not a substitute for a medical diagnosis performed in a clinical setting provided by a healthcare professional. I accept that The BioArte does not take responsibility for the use, by me or my clinician, of the results obtained and any consequences of such use.
    iii. I confirm that the information I have given, both personal and medical, is accurate and truthful. I acknowledge that the clinical team may reach out to me for additional clinical information, which may include details required for research purposes.
    iv. In view of the complexity of the tests, results should be assessed alongside other clinical information by healthcare professionals. Consequently, I agree that the test report may be forwarded to the requesting clinician so that I can be offered the most appropriate advice.
    v. I am not receiving any compensation as the participant nor will I be owed any funds, at this moment or in the future, due to any invention(s) resulting from research and development using my specimen(s).
    vi. I understand that the results of this study may be used for medical or scientific purposes, may be presented, for example, at meetings, in scientific publications, and that they may be reported or published; however, I shall not be personally identified in any way, either individually or collectively.
    vii. I have been informed that this informed consent can be withdrawn at any time.

    Sign the consent with full name and surname. If you are a relative or guardian of the person submitting the sample, kindly sign with your name and surname:

    VAGINAL MICROBIOME QUESTIONNAIRE

    Patient Details

    Date of Examination:


    Predisposing Conditions

    Menopause:

    YesNo

    Pregnancy:

    YesNo

    Diabetes:

    YesNo

    Pre-Menopause:

    YesNo

    Insulin Resistance:

    YesNo

    PCOS:

    YesNo

    Endometriosis:

    YesNo

    Recurrent UTIs / STIs:

    YesNo

    Frequent Candida infection:

    YesNo

    Other predisposing conditions related to vaginal health:

    Sexual Activity

    Sexually active:

    YesNo

    Use of contraceptive drugs or coil:

    YesNo

    Use of an IUD:

    YesNo

    Use of condoms:

    YesNo

    Other contraceptive methods:

    Antimicrobial Use

    Have you taken any antibacterial medicine in the past month?

    YesNo

    Have you taken any antifungal medicine in the past month?

    YesNo

    Medical History

    Type of birth:

    NaturalC-section

    Smoking:

    YesNo

    <20 cigarettes per day>20 cigarettes per day

    Alcohol consumption:

    YesNo

    <10 drinks per week>10 drinks per week

    Autoimmune diseases (specify):

    Medication intake:

    Hormonal therapy:

    YesNo

    Immunosuppression (drugs or otherwise):

    YesNo

    Anti-depressants:

    YesNo

    Antihypertensives / Heart medications:

    YesNo

    Antihistamines / Decongestants:

    YesNo

    Steroids:

    YesNo

    Pre-Probiotic supplements:

    Oral intakeVaginal administrationNone

    Menstrual Insights

    Age at first period:

    <1010-1212-14>14

    Regularity:

    Regular (21-35 days)Irregular (<21 days)Irregular (>35 days)

    Duration:

    Regular (3-7 days)Irregular (<3 days)Irregular (>7 days)

    Last menstrual period:

    Vaginal Hygiene (Optional)

    Frequency of washing the vaginal area:

    More than once dailyOnce dailyLess than once daily

    Name the detergent you use and its pH:

    Frequency of using cotton underwear:

    Every dayOftenRarelyNever

    Additional Questions (Optional)

    Last sexual intercourse:

    <48h ago>48h ago

    Frequency of sexual intercourse:

    Few times per weekFew times per monthFew times per year

    Number of sexual partners in the last 3 months:

    <3 Partners>3 Partners

    Do you use lubricant during sex?

    YesNo

    Oral / Anal sex:

    YesNo

    Use of sex toys:

    YesNo

    Sample Information

    Sample Type:

    VaginalEndocervical

    Date of Swab Collection:

    The part of the menstrual cycle when the swab was taken:

    MenstruationFollicular phase (before ovulation)Ovulation (2 weeks before period)Luteal phase (after ovulation)