Observational Study on Microenvironment and Male Fertility

This study is looking at the relationship between the tiny living organisms (microbiota) in the body and male infertility. Researchers want to understand if certain bacteria in the gut and semen negatively affect fertility. They are also studying how hormone replacement therapy (a treatment for low hormone levels) might be influenced by the gut microbiota in men with infertility and low hormone levels (hypogonadism). You may be able to join if you are an adult man diagnosed with infertility and have not had hormone replacement therapy or used antibiotics in the last six months. The main goal is to understand the types of microbiota present, with results expected after 12 months. The study status is currently unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without providing specific treatments. It plans to enroll 150 men.
What's involved
Participants will provide semen, blood, and rectal swab samples at different times. The specific schedule for these collections is not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, characterization of the microbiota, is measured at 12 months, suggesting a follow-up period of at least this duration.

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NCT04704141

Relationship of the Microenvironment and Male Fertility

UNKNOWN
Not specifiedAges 18+Observational
University of Illinois at Chicago
~150 participants
Updated 2023-04-20 on ClinicalTrials.gov
What's tested:Hormone replacement therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterization of the Microbiota
Measured over 12 months
Male Infertility
Male Hypogonadism

NCT04704141

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Illinois Hospital

    Chicago, Illinoisstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Samuel Ohlander, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

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Eligibility criteria

Inclusion

Men diagnosed with infertility who consent to participate in the study

Exclusion

Prior hormone replacement therapy
Antibiotic use in past 6 months
Inability to consent for self, due to age or mental capacity
Infertility attributable to identifiable causes other than hypogonadism
  • Characterization of the Microbiota12 months

    16S rRNA sequencing of bacterial DNA found in semen and rectal swab samples will be completed on all samples obtained from participants. This will characterize the microbiota profile of each sample.