Relationship of the Microenvironment and Male Fertility

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men diagnosed with infertility who consent to participate in the study

Disqualifiers

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

Trial population

Males referred to University of Illinois Hospital Fertility Services

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Hormone replacement therapy

    Drug

    A hormone replacement regimen using any medication of a number of standard treatment options

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Infertile men with leukocytes in semen and eugonadal0 interventions
Group B: Infertile men without leukocytes in semen and eugonadal0 interventions
Group C: Infertile men with hypogonadism1 intervention

Trial outcomes

Primary outcomes

1

Characterization of the Microbiota

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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