| NCT ID | NCT05328999 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Subfertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-08-10 |
| Primary Completion | 2025-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-08-10 with a primary completion date of 2025-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
With this study, the investigators want to investigate the microbiome and human papilloma virus (HPV) status of couples with subfertility. The investigators want to gain information about association of female and male microbiome and its impact on fertility. HPV prevalence is high, and its impact on fertility has not been studied intensively. The investigators want to find out whether there is an association between HPV status and subfertility, vaginal and seminal microbiome and HPV status and the prevalence among our subfertile couples. As part of this study, the investigators will perform a randomized placebo controlled double blind pilot study to investigate the association between altered sperm quality (impaired motility and elevated DNA fragmentation index), the seminal microbiome and whether intake of probiotics alters these parameters.
Eligibility Criteria
Inclusion Criteria: * Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss. Exclusion Criteria: * unable to consent * diseases or conditions that might impact investigation * intake of probiotics, antibiotics within last 3 months * intake of nutritional supplements * chemo therapy or radiation therapy * excess alcohol intake * smoking
Contact & Investigator
Martina Kollmann, PD Dr.
PRINCIPAL INVESTIGATOR
Medical University of Graz
Frequently Asked Questions
Who can join the NCT05328999 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Subfertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05328999 currently recruiting?
Yes, NCT05328999 is actively recruiting participants. Contact the research team at s.feigl@medunigraz.at for enrollment information.
Where is the NCT05328999 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT05328999 clinical trial?
NCT05328999 is sponsored by Medical University of Graz. The principal investigator is Martina Kollmann, PD Dr. at Medical University of Graz. The trial plans to enroll 300 participants.