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.
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 Type
OBSERVATIONAL
Enrollment
300
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.
Medical University of Graz
Graz, Styria, Austria
RECRUITINGSeminal microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame: 3 months
Vaginal microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame: 1 month
Uterine microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame: 1 month
DNA-Fragmentation index
Rate of sperm with elevated DNA Fragmentation index
Time frame: 3 months
Hormone status of males and females - LH (Luteinizing hormone)
LH status
Time frame: 3 months
Hormone status of males and females - FSH (follicle stimulating hormone)
FSH status
Time frame: 3 months
Hormone status of males and females - Testosterone status
Testosterone status
Time frame: 3 months
Hormone status of males and females - free Testosterone
free Testosterone status
Time frame: 3 months
Hormone status of males and females - Androstenedione
Androstenedione status
Time frame: 3 months
Hormone status of males and females - AMH (Anti-Müllerian hormone)
AMH status
Time frame: 3 months
Hormone status of males and females - DHEAS (dehydroepiandrosterone sulphate)
DHEAS status
Time frame: 3 months
Hormone status of males and females - 25(OH)Vitamin D
25(OH)Vitamin D status
Time frame: 3 months
Hormone status of males and females - TSH (thyroid-stimulating hormone)
TSH status
Time frame: 3 months
Hormone status of males and females - fT3 (free Triiodothyronine)
fT3 Status
Time frame: 3 months
Hormone status of males and females - freeThyroxine (fT4)
fT4 status
Time frame: 3 months
HPV Status
HPV PCR analysis
Time frame: 3 months
stool microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame: 3 months
oral microbiome
16S-RNA sequencing; shotgun metagenomic sequencing
Time frame: 3 months
Cortisol in Saliva
cortisol analysis in saliva of females and males
Time frame: 3 months
Amylase in Saliva
amylase analysis in saliva of females and males
Time frame: 3 months
Metabolic parameters - Omega 3
Omega 3
Time frame: 3 months
Metabolic parameters - Omega 6
Omega 6
Time frame: 3 months
Metabolic parameters - low density lipoprotein
low density lipoprotein
Time frame: 3 months
Metabolic parameters - high density lipoprotein
high density lipoprotein
Time frame: 3 months
Metabolic parameters - triglycerides
triglycerides
Time frame: 3 months
Metabolic parameters - LipoproteinA
LipoproteinA
Time frame: 3 months
Time to pregnancy
Time until clinical pregnancy is achieved
Time frame: 24 months
pregnancy rate
rate of clinical pregnancies
Time frame: 24 months
live birth rate
follow up of pregnancies and their outcome
Time frame: 24 months
Presence of sexual transmittable diseases
HBV, HCV, HIV, Syphilis, Chlamydia, Gardnerella, Trichomonas
Time frame: 3 months
Sperm count
Motility, concentration, morphology
Time frame: 3 months
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