Investigating the microbiome and HPV status in couples facing fertility issues
Fertility and the Microbiome: an Observational Study and Randomized Placebo Controlled Double-blind Pilot Trial
Medical University of Graz · NCT05328999
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Medical University of Graz (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT05328999 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are couples experiencing subfertility, whether due to primary or secondary infertility or recurrent pregnancy loss.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz, Styria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Subfertility, Asthenozoospermia