Assessment of Gonadal Functions in Uremic Male Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04710238
Collaborator
(none)
100
12.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment of Gonadal Functions in Hemodialysis Male Patients on Regular Hemodialysis :A Cross-Sectional Study.
    Anticipated Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Jan 30, 2022
    Anticipated Study Completion Date :
    Feb 28, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    • 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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ali Setohy Hussein Ali, Resident physician ,internal medicine departement , nephrology unite, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04710238
    Other Study ID Numbers:
    • uremic hypogonadism
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali Setohy Hussein Ali, Resident physician ,internal medicine departement , nephrology unite, Assiut University

    Study Results

    No Results Posted as of Jan 14, 2021