Fertility and the Microbiome
Fertility and the Microbiome: an Observational Study and Randomized Placebo Controlled Double-blind Pilot Trial
Medical University of Graz
300 participants
Aug 10, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria1
- Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss.
Exclusion Criteria7
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05328999