ESRDNCT04710238
Assessment of Gonadal Functions in Uremic Male Patients
An observational study of ESRD, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- ESRD
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 28 Feb 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: male patients that were diagnosed to be ESRD on hemodialysis , newly diagnosed and patients on chronic hemodialysis for years
Who may be able to join
- Male patients.
- ESRD on chronic hemodialysis with GFR lower than 15ml/min /1.73 m2
- Age (18_60)years old
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Gonadal Functions in Hemodialysis Male Patients on Regular Hemodialysis :A Cross-Sectional Study.
- Study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) .
- Study the effect of hemodialysis on the male patients sexual functions by measurement of serum prolactin and free testosterone levels.
Read the 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.
- Conditions
- ESRD
- Keywords
- uremic hypogonadism, free testosterone level, serum prolactin
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the prevalence of sexual dysfunction in male patients on hemodialysis .
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 .
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Setohy Hussein Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710238
- Sponsor's protocol ID
- uremic hypogonadism
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27586847Antonucci 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.
PubMed 26766802Foulks 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.
PubMed 3532769Fiuk 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.
PubMed 31080776
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gonadal Functions in Hemodialysis Male Patients on Regular Hemodialysis :A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT04710238
- Acronym / sponsor ID
- uremic hypogonadism
- Conditions
- ESRD
- Keywords
- uremic hypogonadism, free testosterone level, serum prolactin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) .
- 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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- male patients that were diagnosed to be ESRD on hemodialysis , newly diagnosed and patients on chronic hemodialysis for years
Key inclusion criteria (3 listed)
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the prevalence of sexual dysfunction in male patients on hemodialysis .
Time frame: 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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 27586847Palmer 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.
- Background: PubMed 26766802Antonucci 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.
- Background: PubMed 3532769Foulks 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.
- Results publication: PubMed 31080776Fiuk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ali setohy hussien, M.B.B.ch (01020462809, setohy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the prevalence of sexual dysfunction in male patients on hemodialysis . (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710238, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.