Relationship of the Microenvironment and Male Fertility

Conditions

• Male Hypogonadism
• Male Infertility

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hormone replacement therapy — DRUG
  A hormone replacement regimen using any medication of a number of standard treatment options

Study Details

Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets. The investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million/mL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status. Participants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically \>1 mL, and \<0.2 mL is typically used for the semen analysis. If over 1 million/mL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis. Secondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.

Key Dates

Start date

Jun 30, 2023

Status verified

Apr 2023

Primary completion

Jun 30, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: Infertile men with leukocytes in semen and eugonadal
  Standard fertility evaluation and treatments
• Arm: Infertile men without leukocytes in semen and eugonadal
  Standard fertility evaluation and treatments
• Arm: Infertile men with hypogonadism
  Standard fertility evaluation and treatments, including hormone replacement therapy such as with clomiphene citrate

Primary Outcome Measure

Characterization of the Microbiota [ Time Frame: 12 months ]

Central Contacts

• Samuel Ohlander, MD
  312-996-9330
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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