Assessment of Gonadal Functions in Uremic Male Patients

NCT ID: NCT04710238

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-02-28

Brief Summary

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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

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: 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.

Conditions

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ESRD

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali Setohy Hussein Ali

Resident physician ,internal medicine departement , nephrology unite

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ali setohy hussien, M.B.B.ch

Role: CONTACT

01020462809

Manal Elsayed Ez eldeen, prof.

Role: CONTACT

01005826070

References

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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.

Reference Type BACKGROUND
PMID: 27586847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26766802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3532769 (View on PubMed)

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.

Reference Type RESULT
PMID: 31080776 (View on PubMed)

Other Identifiers

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uremic hypogonadism

Identifier Type: -

Identifier Source: org_study_id

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