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RecruitingNCT05328999Updated Jul 24, 2024

Fertility and the Microbiome

An observational study in Subfertility and Asthenozoospermia, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Primary conditionAsthenozoospermiaRegistry: InfertilityReclassifiedWhy we changed it
Registry
Infertility — the first condition term the registry derived for this study.
ClinicalTrials.gg
Asthenozoospermia
Why
  1. The study's listed conditions name Asthenozoospermia, a narrower term within Infertility.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Subfertility
  • Asthenozoospermia

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03

In context

Asthenozoospermia Reclassified

32 studies on the registry are indexed under Asthenozoospermia; 9 are open to participants now.

Browse Asthenozoospermia studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Browse Medical University of Graz studies →

Compared within Asthenozoospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Subfertile patients

    Males and females between 18 and 50 years of age with subfertility presenting at the fertility center at the Medical University of Graz.

  • Subfertile males with elevated DNA fragmentation index and asthenozoospermia

    Males between 18 and 50 years of age with elevated DNA fragmentation index and asthenozoospermia presenting at the fertility center at the Medical University of Graz.

    Dietary Supplement: Probiotics (Omnibiotic (R))

Interventions

  • Dietary supplementProbiotics (Omnibiotic (R))

    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.

06

What researchers measure

Primary outcomes

  1. Seminal microbiome

    16S-RNA sequencing; shotgun metagenomic sequencing

    Time frame: 3 months

  2. Vaginal microbiome

    16S-RNA sequencing; shotgun metagenomic sequencing

    Time frame: 1 month

  3. Uterine microbiome

    16S-RNA sequencing; shotgun metagenomic sequencing

    Time frame: 1 month

  4. DNA-Fragmentation index

    Rate of sperm with elevated DNA Fragmentation index

    Time frame: 3 months

Secondary outcomes

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

    LH status

    Time frame: 3 months

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

    FSH status

    Time frame: 3 months

  3. Hormone status of males and females - Testosterone status

    Testosterone status

    Time frame: 3 months

  4. Hormone status of males and females - free Testosterone

    free Testosterone status

    Time frame: 3 months

  5. Hormone status of males and females - Androstenedione

    Androstenedione status

    Time frame: 3 months

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

    AMH status

    Time frame: 3 months

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

    DHEAS status

    Time frame: 3 months

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

    25(OH)Vitamin D status

    Time frame: 3 months

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

    TSH status

    Time frame: 3 months

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

    fT3 Status

    Time frame: 3 months

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

    fT4 status

    Time frame: 3 months

  12. HPV Status

    HPV PCR analysis

    Time frame: 3 months

  13. stool microbiome

    16S-RNA sequencing; shotgun metagenomic sequencing

    Time frame: 3 months

  14. oral microbiome

    16S-RNA sequencing; shotgun metagenomic sequencing

    Time frame: 3 months

  15. Cortisol in Saliva

    cortisol analysis in saliva of females and males

    Time frame: 3 months

  16. Amylase in Saliva

    amylase analysis in saliva of females and males

    Time frame: 3 months

  17. Metabolic parameters - Omega 3

    Omega 3

    Time frame: 3 months

  18. Metabolic parameters - Omega 6

    Omega 6

    Time frame: 3 months

  19. Metabolic parameters - low density lipoprotein

    low density lipoprotein

    Time frame: 3 months

  20. Metabolic parameters - high density lipoprotein

    high density lipoprotein

    Time frame: 3 months

  21. Metabolic parameters - triglycerides

    triglycerides

    Time frame: 3 months

  22. Metabolic parameters - LipoproteinA

    LipoproteinA

    Time frame: 3 months

  23. Time to pregnancy

    Time until clinical pregnancy is achieved

    Time frame: 24 months

  24. pregnancy rate

    rate of clinical pregnancies

    Time frame: 24 months

  25. live birth rate

    follow up of pregnancies and their outcome

    Time frame: 24 months

  26. Presence of sexual transmittable diseases

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

    Time frame: 3 months

  27. Sperm count

    Motility, concentration, morphology

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Jersoviene V, Gudleviciene Z, Rimiene J, Butkauskas D. Human Papillomavirus and Infertility. Medicina (Kaunas). 2019 Jul 15;55(7):377. doi: 10.3390/medicina55070377. PubMed 31311196 ↗
  • Brusselaers N, Shrestha S, van de Wijgert J, Verstraelen H. Vaginal dysbiosis and the risk of human papillomavirus and cervical cancer: systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):9-18.e8. doi: 10.1016/j.ajog.2018.12.011. Epub 2018 Dec 12. PubMed 30550767 ↗
  • Koedooder R, Singer M, Schoenmakers S, Savelkoul PHM, Morre SA, de Jonge JD, Poort L, Cuypers WJSS, Beckers NGM, Broekmans FJM, Cohlen BJ, den Hartog JE, Fleischer K, Lambalk CB, Smeenk JMJS, Budding AE, Laven JSE. The vaginal microbiome as a predictor for outcome of in vitro fertilization with or without intracytoplasmic sperm injection: a prospective study. Hum Reprod. 2019 Jun 4;34(6):1042-1054. doi: 10.1093/humrep/dez065. Erratum In: Hum Reprod. 2019 Oct 2;34(10):2091-2092. doi: 10.1093/humrep/dez127. PubMed 31119299 ↗
  • Depuydt CE, Donders GGG, Verstraete L, Vanden Broeck D, Beert JFA, Salembier G, Bosmans E, Ombelet W. Infectious human papillomavirus virions in semen reduce clinical pregnancy rates in women undergoing intrauterine insemination. Fertil Steril. 2019 Jun;111(6):1135-1144. doi: 10.1016/j.fertnstert.2019.02.002. Epub 2019 Apr 17. PubMed 31005311 ↗
  • Baud D, Pattaroni C, Vulliemoz N, Castella V, Marsland BJ, Stojanov M. Sperm Microbiota and Its Impact on Semen Parameters. Front Microbiol. 2019 Feb 12;10:234. doi: 10.3389/fmicb.2019.00234. eCollection 2019. PubMed 30809218 ↗
  • Koedooder R, Singer M, Schoenmakers S, Savelkoul PHM, Morre SA, de Jonge JD, Poort L, Cuypers WSS, Budding AE, Laven JSE; ReceptIVFity study group. The ReceptIVFity cohort study protocol to validate the urogenital microbiome as predictor for IVF or IVF/ICSI outcome. Reprod Health. 2018 Dec 7;15(1):202. doi: 10.1186/s12978-018-0653-x. PubMed 30526664 ↗
  • Depuydt CE, Donders G, Verstraete L, Vanden Broeck D, Beert J, Salembier G, Bosmans E, DhontT N, Van Der Auwera I, Vandenborne K, Ombelet W. Time has come to include Human Papillomavirus (HPV) testing in sperm donor banks. Facts Views Vis Obgyn. 2018 Dec;10(4):201-205. PubMed 31367292 ↗
  • Xiong YQ, Chen YX, Cheng MJ, He WQ, Chen Q. The risk of human papillomavirus infection for male fertility abnormality: a meta-analysis. Asian J Androl. 2018 Sep-Oct;20(5):493-497. doi: 10.4103/aja.aja_77_17. PubMed 29623908 ↗
  • Moreno I, Simon C. Relevance of assessing the uterine microbiota in infertility. Fertil Steril. 2018 Aug;110(3):337-343. doi: 10.1016/j.fertnstert.2018.04.041. PubMed 30098680 ↗
  • Simon C. Introduction: Do microbes in the female reproductive function matter? Fertil Steril. 2018 Aug;110(3):325-326. doi: 10.1016/j.fertnstert.2018.06.041. Epub 2018 Jul 20. PubMed 30037698 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05328999
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Aug 10, 2022
Primary completion
Apr 11, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 24, 2024

Study contacts

Sarah Feigl, Dr.
Contact
s.feigl@medunigraz.at
004331638580831
Martina Kollmann, PD Dr.
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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