Clinical trial NCT04710238: Assessment of Gonadal Functions in Uremic Male Patients
Official title: Assessment of Gonadal Functions in Hemodialysis Male Patients on Regular Hemodialysis :A Cross-Sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Keywords: uremic hypogonadism
free testosterone level
serum prolactin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male patients that were diagnosed to be ESRD on hemodialysis , newly diagnosed and patients on chronic hemodialysis for years

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.

Eligibility criteria: * Inclusion Criteria

  1. Male patients.
  2. ESRD on chronic hemodialysis with GFR lower than 15ml/min /1.73 m2
  3. Age (18_60)years old
* 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 .

Primary outcomes:
measure: Study the prevalence of sexual dysfunction in male patients on hemodialysis .
timeFrame: base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Palmer BF, Clegg DJ. Gonadal dysfunction in chronic kidney disease. Rev Endocr Metab Disord. 2017 Mar;18(1):117-130. doi: 10.1007/s11154-016-9385-9.
citation: Antonucci M, Palermo G, Recupero SM, Bientinesi R, Presicce F, Foschi N, Bassi P, Gulino G. Male sexual dysfunction in patients with chronic end-stage renal insufficiency and in renal transplant recipients. Arch Ital Urol Androl. 2016 Jan 14;87(4):299-305. doi: 10.4081/aiua.2015.4.299.
citation: Foulks CJ, Cushner HM. Sexual dysfunction in the male dialysis patient: pathogenesis, evaluation, and therapy. Am J Kidney Dis. 1986 Oct;8(4):211-22. doi: 10.1016/s0272-6386(86)80029-4.
citation: Fiuk JV, Tadros NN. Erectile dysfunction in renal failure and transplant patients. Transl Androl Urol. 2019 Apr;8(2):155-163. doi: 10.21037/tau.2018.09.04.