Assessment of Gonadal Functions in Uremic Male Patients

• Conditions: ESRD

• Registration Number: NCT04710238
• Lead Sponsor: Assiut University

Brief Summary

1. Study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) .

2. Study the effect of hemodialysis on the male patients sexual functions by measurement of serum prolactin and free testosterone levels.

Detailed Description

: Gonadal dysfunction is a frequent finding in men with ESRD on chronic hemodialysis ,erectile dysfunction is one of the most common manifestation of sexual dysfuncion whitch has been reported to be as high as 70 -80 %of hemodialysis patients .

Testosterone deficiency and insufficiency are frequent findings in hemodialysis male patients that were found to be 66% and 24% respectively The Probleme is multifactorial , the most important factor is due to testesterone deficiency. total and free testosterone levels are typically reduced , that is usually accompanied by elevation of serum Gonadotropins concentrations due to hypothalamic -pituitary-gonadal -axis disturbance(uremic hypogonadism) .

Alterations in the pulsatile release of GnRH, which leads to a hypogondal state due to uremia, which occurs due to inadequate nutrient intake, stress, and systemic illness . Excess LH secretion is thought to result from the diminished release of testosterone from the Leydig cells, because testosterone normally provides a feedback inhibition of LH release. The metabolic clearance rate of LH is reduced due to reduction of kidney clearance ,Follicle stimulating hormone (FSH) secretion is also increased in men with chronic kidney failure.

Elevated plasma prolactin levels are commonly found in dialyzed men, it is thought to be due to increased its production , extreme hyperprolactinemia has been associated with infertility, loss of libido, low circulating testosterone levels, So,due to testosterone deficiency and hyperprolactinemia in ESRD as one of most important factors and exclusion of other factors , men on chronic hemodialysis shows different degrees of subfertility or infertility due to Erectile dysfunction , testicular damage and impaired spermatogenesis.

Study Timeline

• Study First Submitted: 2020-09-27
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14
• Study Start: 2021-02-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1-Diabetic patients . 3-hypertesive patients . 3-Patients with primary infertility before the event of ESRD and Starting dialysis.

4-Manifest hypothyroidism . 5-Patient with other causes that may lead to subfertility as varicocele . 6-patients with previous exposure to head and genital trauma , surgery or irradiation .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the prevalence of sexual dysfunction in male patients on hemodialysis .	base line	Knowning the degree of sexual dysfunctions prevalence in male patients on hemodialysis and evaluation of the associated factors of gonadal dysfunction in male patients on hemodialysis .