Human Papillomavirus and Infertility.
Vilma Jeršovienė, Živilė Gudlevičienė, Jolita Rimienė...
https://pubmed.ncbi.nlm.nih.gov/31311196Actively Recruiting
Age: 18Years - 50Years
All Genders
ID05328999
Fertility and the Microbiome: an Observational Study and Randomized Placebo Controlled Double-blind Pilot Trial
Led by Medical University of Graz · Updated on 2024-07-24
300
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between the microbiome and human papilloma virus (HPV) status in couples experiencing subfertility. The study aims to understand how the female and male microbiomes might affect fertility and to explore the prevalence and impact of HPV on subfertility. This research includes an observational study and a randomized placebo-controlled double-blind pilot trial focusing on sperm quality and microbiome changes. The study will enroll 150 couples over 24 months, collecting samples from various sites including oral, urinary, stool, vaginal, uterine, and seminal areas for microbiome and HPV analysis. Additional tests will assess sexually transmitted diseases, hormone levels, and metabolic status. In the pilot trial, 30 subfertile men with specific sperm impairments will be randomly assigned to receive either probiotics or a placebo daily for 3 months, with sperm count and microbiome evaluations before and after treatment. Participants will undergo multiple assessments including microbiome analyses, hormone and metabolic testing, and HPV screening. Researchers will track outcomes such as time to pregnancy, pregnancy rates, live birth rates, and sperm DNA fragmentation over periods ranging from 1 month to 24 months. The study carefully monitors changes related to probiotic intake and collects extensive biological samples to understand fertility-related factors in subfertile couples.
CONDITIONS
Brief Title
Fertility and the Microbiome
Who Can Participate
Age: 18Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Couples (males and females) with subfertility, primary or secondary infertility, or recurrent pregnancy loss
- Age between 18 and 50 years
- Ability to provide informed consent
You will not qualify if you...
- Unable to consent
- Diseases or conditions that may affect the study
- Use of probiotics or antibiotics within the last 3 months
- Use of nutritional supplements
- Previous chemotherapy or radiation therapy
- Excessive alcohol intake
- Smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 24 months
Participants provide microbiome and sample collections for oral, urinary, stool, vaginal, uterine, and seminal analysis, as well as testing for HPV, sexually transmittable diseases, hormone status, and metabolic status.
Visits occur as needed for sample collection and assessments over 24 months
Treatment
Duration - 3 months
Subfertile males with elevated DNA fragmentation index and asthenozoospermia receive either probiotics or placebo daily for 3 months to evaluate effects on sperm count and microbiome.
1 baseline visit and 1 visit after 3 months
Trial Site Locations
Total: 1 location
1
Medical University of Graz
Graz, Styria, Austria, 8036
Actively Recruiting
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Research Team
S
Sarah Feigl, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Vaginal dysbiosis and the risk of human papillomavirus and cervical cancer: systematic review and meta-analysis.
Nele Brusselaers, Sadeep Shrestha, Janneke van de Wijgert...
https://pubmed.ncbi.nlm.nih.gov/30550767The vaginal microbiome as a predictor for outcome of in vitro fertilization with or without intracytoplasmic sperm injection: a prospective study.
R Koedooder, M Singer, S Schoenmakers...
https://pubmed.ncbi.nlm.nih.gov/31119299Infectious human papillomavirus virions in semen reduce clinical pregnancy rates in women undergoing intrauterine insemination.
Christophe Eric Depuydt, Gilbert Ghislain Gerard Donders, Ludo Verstraete...
https://pubmed.ncbi.nlm.nih.gov/31005311Sperm Microbiota and Its Impact on Semen Parameters.
David Baud, Céline Pattaroni, Nicolas Vulliemoz...
https://pubmed.ncbi.nlm.nih.gov/30809218The ReceptIVFity cohort study protocol to validate the urogenital microbiome as predictor for IVF or IVF/ICSI outcome.
Rivka Koedooder, Martin Singer, Sam Schoenmakers...
https://pubmed.ncbi.nlm.nih.gov/30526664Time has come to include Human Papillomavirus (HPV) testing in sperm donor banks.
C E Depuydt, Ggg Donders, L Verstraete...
https://pubmed.ncbi.nlm.nih.gov/31367292The risk of human papillomavirus infection for male fertility abnormality: a meta-analysis.
Yi-Quan Xiong, Yan-Xia Chen, Ming-Ji Cheng...
https://pubmed.ncbi.nlm.nih.gov/29623908Relevance of assessing the uterine microbiota in infertility.
Inmaculada Moreno, Carlos Simon
https://pubmed.ncbi.nlm.nih.gov/30098680Introduction: Do microbes in the female reproductive function matter?
Carlos Simon
https://pubmed.ncbi.nlm.nih.gov/30037698