Clinical trial Recruiting at 1 site Observational Ages 18 to 50

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 typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment300 (estimated)
SponsorMedical University of Graz
Academic / other
Drugs / interventionsradiation
Locations1 site (Graz, Styria)
StatusRecruiting
StartedAugust 10, 2022
Main results expectedApril 11, 2025
Study endsDecember 31, 2026
Registry record updatedJuly 24, 2024
Trial IDNCT05328999 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

  • Medical University of Graz
    Graz, Styria, Austria
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.