Fertility and the Microbiome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorMedical University of Graz
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss.
Disqualifiers
unable to consent
diseases or conditions that might impact investigation
intake of probiotics, antibiotics within last 3 months
intake of nutritional supplements
Trial population
Couples (Males and females) with subfertility, primary or secundary infertility, or recurrent pregnancy loss.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Probiotics (Omnibiotic (R))
Dietary supplementAs 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Subfertile patients0 interventions
Group B: Subfertile males with elevated DNA fragmentation index and asthenozoospermia1 intervention
Trial outcomes
Primary outcomes
1
Seminal microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame
3 months2
Vaginal microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame
1 month3
Uterine microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame
1 month4
DNA-Fragmentation index
Rate of sperm with elevated DNA Fragmentation index
Time frame
3 monthsSecondary outcomes
1
Hormone status of males and females - LH (Luteinizing hormone)
LH status
Time frame
3 months2
Hormone status of males and females - FSH (follicle stimulating hormone)
FSH status
Time frame
3 months3
Hormone status of males and females - Testosterone status
Testosterone status
Time frame
3 months4
Hormone status of males and females - free Testosterone
free Testosterone status
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov