Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05328999
Other study ID # Fertilitom
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 10, 2022
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Medical University of Graz
Contact Sarah Feigl, Dr.
Phone 004331638580831
Email s.feigl@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date April 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotics (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.

Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Seminal microbiome 16S-RNA sequencing; shotgun metagenomic sequencing 3 months
Primary Vaginal microbiome 16S-RNA sequencing; shotgun metagenomic sequencing 1 month
Primary Uterine microbiome 16S-RNA sequencing; shotgun metagenomic sequencing 1 month
Primary DNA-Fragmentation index Rate of sperm with elevated DNA Fragmentation index 3 months
Secondary Hormone status of males and females - LH (Luteinizing hormone) LH status 3 months
Secondary Hormone status of males and females - FSH (follicle stimulating hormone) FSH status 3 months
Secondary Hormone status of males and females - Testosterone status Testosterone status 3 months
Secondary Hormone status of males and females - free Testosterone free Testosterone status 3 months
Secondary Hormone status of males and females - Androstenedione Androstenedione status 3 months
Secondary Hormone status of males and females - AMH (Anti-Müllerian hormone) AMH status 3 months
Secondary Hormone status of males and females - DHEAS (dehydroepiandrosterone sulphate) DHEAS status 3 months
Secondary Hormone status of males and females - 25(OH)Vitamin D 25(OH)Vitamin D status 3 months
Secondary Hormone status of males and females - TSH (thyroid-stimulating hormone) TSH status 3 months
Secondary Hormone status of males and females - fT3 (free Triiodothyronine) fT3 Status 3 months
Secondary Hormone status of males and females - freeThyroxine (fT4) fT4 status 3 months
Secondary HPV Status HPV PCR analysis 3 months
Secondary stool microbiome 16S-RNA sequencing; shotgun metagenomic sequencing 3 months
Secondary oral microbiome 16S-RNA sequencing; shotgun metagenomic sequencing 3 months
Secondary Cortisol in Saliva cortisol analysis in saliva of females and males 3 months
Secondary Amylase in Saliva amylase analysis in saliva of females and males 3 months
Secondary Metabolic parameters - Omega 3 Omega 3 3 months
Secondary Metabolic parameters - Omega 6 Omega 6 3 months
Secondary Metabolic parameters - low density lipoprotein low density lipoprotein 3 months
Secondary Metabolic parameters - high density lipoprotein high density lipoprotein 3 months
Secondary Metabolic parameters - triglycerides triglycerides 3 months
Secondary Metabolic parameters - LipoproteinA LipoproteinA 3 months
Secondary Time to pregnancy Time until clinical pregnancy is achieved 24 months
Secondary pregnancy rate rate of clinical pregnancies 24 months
Secondary live birth rate follow up of pregnancies and their outcome 24 months
Secondary Presence of sexual transmittable diseases HBV, HCV, HIV, Syphilis, Chlamydia, Gardnerella, Trichomonas 3 months
Secondary Sperm count Motility, concentration, morphology 3 months
See also
  Status Clinical Trial Phase
Completed NCT03569787 - Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire
Completed NCT03105453 - The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
Terminated NCT02180256 - Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial N/A
Terminated NCT02197832 - A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles N/A
Completed NCT00971152 - Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle Phase 3
Completed NCT01569945 - Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur N/A
Recruiting NCT04064840 - GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET Phase 3
Recruiting NCT02561793 - DHEA Versus Placebo in Women With Poor Ovarian Response Phase 3
Terminated NCT02570386 - Clinical Effectiveness of Frozen Thawed Embryo Transfer Compared to Fresh Embryo Transfer N/A
Completed NCT02197208 - A RCT Comparing Spontaneous Natural Cycles and Human Chorionic Gonadotrophin-induced Natural Cycles in FET N/A
Completed NCT01961336 - Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF Phase 3
Completed NCT02487940 - Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure Phase 4
Completed NCT01385618 - Gene-polymorphisms Relating to Human Subfertility N/A
Completed NCT00985062 - Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization N/A
Recruiting NCT04538560 - Preimplantation Genetic Testing for Aneuploidy of Polar Bodies N/A
Completed NCT02748278 - Comparison of the Number of Oocytes Obtained Between Chinese and Caucasian Women in IVF Treatment
Completed NCT02044445 - Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval? N/A
Completed NCT02863614 - Analgesia for Endometrial Scratching N/A
Completed NCT02151006 - Does Dehydro Epiandrosterone (DHEA) Improve Pregnancy Rate in Women Undergoing IVF/ICSI With Expected Poor Ovarian Response? Phase 3
Completed NCT02154958 - Role of Follicular Output Rate in the Prediction of in Vitro Fertilization and Intracytoplasmic Sperm Injection in Women With Unexplained Infertility N/A