Fertility and the Microbiome

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Seminal microbiome — 3 months
  16S-RNA sequencing; shotgun metagenomic sequencing
• Vaginal microbiome — 1 month
  16S-RNA sequencing; shotgun metagenomic sequencing
• Uterine microbiome — 1 month
  16S-RNA sequencing; shotgun metagenomic sequencing
• DNA-Fragmentation index — 3 months
  Rate of sperm with elevated DNA Fragmentation index

Trial sites (1)

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