Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05328999

Fertility and the Microbiome

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Subfertility Asthenozoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Couples (Males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss.

Exclusion criteria

  • 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

Treatment and study plan

Probiotics (Omnibiotic (R))

Dietary Supplement

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.

Primary outcomes

  1. Seminal microbiome

    Time frame: 3 months

    16S-RNA sequencing; shotgun metagenomic sequencing

  2. Vaginal microbiome

    Time frame: 1 month

    16S-RNA sequencing; shotgun metagenomic sequencing

  3. Uterine microbiome

    Time frame: 1 month

    16S-RNA sequencing; shotgun metagenomic sequencing

  4. DNA-Fragmentation index

    Time frame: 3 months

    Rate of sperm with elevated DNA Fragmentation index

Secondary outcomes

  1. Hormone status of males and females - LH (Luteinizing hormone)

    Time frame: 3 months

    LH status

  2. Hormone status of males and females - FSH (follicle stimulating hormone)

    Time frame: 3 months

    FSH status

  3. Hormone status of males and females - Testosterone status

    Time frame: 3 months

    Testosterone status

  4. Hormone status of males and females - free Testosterone

    Time frame: 3 months

    free Testosterone status

  5. Hormone status of males and females - Androstenedione

    Time frame: 3 months

    Androstenedione status

  6. Hormone status of males and females - AMH (Anti-Müllerian hormone)

    Time frame: 3 months

    AMH status

  7. Hormone status of males and females - DHEAS (dehydroepiandrosterone sulphate)

    Time frame: 3 months

    DHEAS status

  8. Hormone status of males and females - 25(OH)Vitamin D

    Time frame: 3 months

    25(OH)Vitamin D status

  9. Hormone status of males and females - TSH (thyroid-stimulating hormone)

    Time frame: 3 months

    TSH status

  10. Hormone status of males and females - fT3 (free Triiodothyronine)

    Time frame: 3 months

    fT3 Status

  11. Hormone status of males and females - freeThyroxine (fT4)

    Time frame: 3 months

    fT4 status

  12. HPV Status

    Time frame: 3 months

    HPV PCR analysis

  13. stool microbiome

    Time frame: 3 months

    16S-RNA sequencing; shotgun metagenomic sequencing

  14. oral microbiome

    Time frame: 3 months

    16S-RNA sequencing; shotgun metagenomic sequencing

  15. Cortisol in Saliva

    Time frame: 3 months

    cortisol analysis in saliva of females and males

  16. Amylase in Saliva

    Time frame: 3 months

    amylase analysis in saliva of females and males

  17. Metabolic parameters - Omega 3

    Time frame: 3 months

    Omega 3

  18. Metabolic parameters - Omega 6

    Time frame: 3 months

    Omega 6

  19. Metabolic parameters - low density lipoprotein

    Time frame: 3 months

    low density lipoprotein

  20. Metabolic parameters - high density lipoprotein

    Time frame: 3 months

    high density lipoprotein

  21. Metabolic parameters - triglycerides

    Time frame: 3 months

    triglycerides

  22. Metabolic parameters - LipoproteinA

    Time frame: 3 months

    LipoproteinA

  23. Time to pregnancy

    Time frame: 24 months

    Time until clinical pregnancy is achieved

  24. pregnancy rate

    Time frame: 24 months

    rate of clinical pregnancies

  25. live birth rate

    Time frame: 24 months

    follow up of pregnancies and their outcome

  26. Presence of sexual transmittable diseases

    Time frame: 3 months

    HBV, HCV, HIV, Syphilis, Chlamydia, Gardnerella, Trichomonas

  27. Sperm count

    Time frame: 3 months

    Motility, concentration, morphology

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Feigl, Dr.

CONTACT

[email protected]

004331638580831

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.