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Fertility and the Microbiome

Subfertility Clinical Trial

Official title:
Fertility and the Microbiome: an Observational Study and Randomized Placebo Controlled Double-blind Pilot Trial

Clinical Trial 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.

Clinical Trial Description

Observational study: The investigators will include 150 couples within 24 months and will take samples of oral, urinary, stool, vaginal, uterine and seminal microbiome and cervical as well as seminal samples for HPV analysis. Further, the investigators will test for other sexually transmittable diseases, hormone status and metabolic status. Time to pregnancy, pregnancy rate and live birth rate will be evaluated. Placebo controlled double blind randomized controlled trial: 30 subfertile men (Asthenozoospermia, elevated DNA fragmentation index) will be randomized in to two groups: Placebo or Probiotics for 3 months daily. Before and after these 3 months, sperm count microbiome analysis and HPV analysis will be performed to find possible associations with intake of probiotics. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05328999
Study type Observational
Source Medical University of Graz
Contact Sarah Feigl, Dr.
Phone 004331638580831
Email s.feigl@medunigraz.at
Status Recruiting
Phase
Start date August 10, 2022
Completion date December 31, 2024
View Details
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