Fertility and the Microbiome

NCT05328999 | Recruiting

• 1 other identifier: Fertilitom
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subfertility; Asthenozoospermia

Outcome Measures

Primary Outcomes (4)

• Seminal microbiome

  16S-RNA sequencing; shotgun metagenomic sequencing

  3 months

• Vaginal microbiome

  16S-RNA sequencing; shotgun metagenomic sequencing

  1 month

• Uterine microbiome

  16S-RNA sequencing; shotgun metagenomic sequencing

  1 month

• DNA-Fragmentation index

  Rate of sperm with elevated DNA Fragmentation index

  3 months

Secondary Outcomes (27)

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

  3 months

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

  3 months

• Hormone status of males and females - Testosterone status

  3 months

• Hormone status of males and females - free Testosterone

  3 months

• Hormone status of males and females - Androstenedione

  3 months

Study Arms (2)

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

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.

Subfertile males with elevated DNA fragmentation index and asthenozoospermia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

RECRUITING

Related Publications (10)

• Jersoviene V, Gudleviciene Z, Rimiene J, Butkauskas D. Human Papillomavirus and Infertility. Medicina (Kaunas). 2019 Jul 15;55(7):377. doi: 10.3390/medicina55070377.

  PMID: 31311196 BACKGROUND

• 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.

  PMID: 30550767 BACKGROUND

• 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.

  PMID: 31119299 BACKGROUND

• 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.

  PMID: 31005311 BACKGROUND

• 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.

  PMID: 30809218 BACKGROUND

• 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.

  PMID: 30526664 BACKGROUND

• 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.

  PMID: 31367292 BACKGROUND

• 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.

  PMID: 29623908 BACKGROUND

• 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.

  PMID: 30098680 BACKGROUND

• 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.

  PMID: 30037698 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Oral swabs, vaginal swabs, uterine swabs, cervical swabs, urine, ejaculate, stool samples.

MeSH Terms

Conditions

Infertility; Asthenozoospermia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Infertility, Male; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Martina Kollmann, PD Dr.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Feigl, Dr.

CONTACT

004331638580831; s.feigl@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: August 10, 2022
• Primary Completion: April 11, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

AU (1)