Investigating the microbiome and HPV status in couples facing fertility issues
Official title: Fertility and the Microbiome: an Observational Study and Randomized Placebo Controlled Double-blind Pilot Trial
Run by Medical University of Graz · NCT05328999 · Data updated 2026-11-12
This study is looking at how the bacteria in the body and HPV might affect couples trying to get pregnant, while also testing if probiotics can improve sperm quality in men with fertility issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Graz, Styria) |
| Status | Recruiting |
| Started | August 10, 2022 |
| Main results expected | April 11, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 24, 2024 |
| Trial ID | NCT05328999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are couples experiencing subfertility, whether due to primary or secondary infertility or recurrent pregnancy loss.
✕Probably not a fit
Patients who have recently taken probiotics, antibiotics, or nutritional supplements, or those with conditions affecting the investigation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between the microbiome and human papilloma virus (HPV) status in couples experiencing subfertility. The study will involve 150 couples over 24 months, collecting samples from various microbiomes and conducting HPV analysis. Additionally, a randomized placebo-controlled pilot study will assess the effects of probiotics on sperm quality in 30 subfertile men with asthenozoospermia. The outcomes will include time to pregnancy, pregnancy rates, and live birth rates.
Why it matters
Potential benefit: If successful, this study could provide insights into how microbiome health and HPV status affect fertility, potentially leading to new treatment options.
How similar studies have gone: While the association between microbiome and fertility is an emerging field, this specific approach combining microbiome analysis with HPV status in subfertile couples is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Medical University of Graz
Graz, Styria, Austria Recruiting
Study contacts
- Principal investigator: Martina Kollmann, PD Dr. — Medical University of Graz
- Study coordinator: Sarah Feigl, Dr.
- Email: s.feigl@medunigraz.at
- Phone: 004331638580831
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.