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Fertility and the Microbiome

NCT05328999 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-07-24

No results posted yet for this study

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.

Conditions

  • Subfertility
  • Asthenozoospermia

Interventions

DIETARY_SUPPLEMENT

Probiotics (Omnibiotic (R))

As intervention in the randomized placebo controlled double blind trial, 30 males will receive either probiotics or placebo once daily for 3 months. Sperm count and microbiome analysis before and after intervention will be performed.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Martina Kollmann, PD Dr. · Medical University of Graz

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2025-04-11
Completion
2026-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328999 on ClinicalTrials.gov