What is this study trying to find out about subfertility?

This study aims to explore how the microbiome and HPV status in couples with subfertility relate to fertility outcomes. Researchers want to understand the connection between male and female microbiomes, HPV prevalence, and subfertility. The Medical University of Graz is leading this research to improve knowledge of these factors in fertility.

Who may be eligible for this subfertility clinical trial?

Adults aged 18 to 50 years with subfertility or recurrent pregnancy loss may be eligible. Both males and females can participate, but people who have used probiotics, antibiotics, or nutritional supplements recently may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this subfertility clinical trial?

Study-related care, including all tests and study visits, is provided at no cost. Personal travel and other expenses may not be covered and can vary. Participants should plan accordingly for any costs associated with attending visits.

Actively Recruiting

Age: 18Years - 50Years

All Genders

ID05328999

Study on Fertility and Microbiome in Couples with Subfertility Including a Probiotics Trial for Men with Sperm Issues

Led by Medical University of Graz · Updated on 2024-07-24

300

Participants Needed

Research Sites

89 weeks

Total Duration

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

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