Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
1 other identifier
observational
90
0 countries
N/A
Brief Summary
Normal testicular hormonal and spermatogenic function depends not only on the testis itself, but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has been shown to influence male gonadal function in variety of ways, leading to reduced libido, erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle mass. The effect of systemic diseases may occur directly at the testicular level: reduced Leydig cell function will lead to androgen deficiency, while diseases affecting Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 30, 2017
May 1, 2017
1 year
May 23, 2017
May 24, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Semen parameters (volume, total sperm count and sperm concentration, motility and morphology)
Mean difference in semen parameters(volume, total sperm count and sperm concentration, motility and morphology) between patients and control group
Baseline
Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)
Mean difference in serum level of reproductive hormones(free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) between patients and control group
Baseline
Study Arms (2)
Patients group
Male patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done
Control group
Healthy males without history or features of liver disease. Laboratory tests will be done
Interventions
Semen analysis and reproductive hormonal assay (free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) for both patients and control group
Eligibility Criteria
male patients with liver cirrhosis will be recruited from the department of gastroenterology and tropical medicine and other group of healthy males without history or features of liver disease serves as the control group will be recruited from the outpatient clinics at Assiut university hospital.
You may qualify if:
- male patient with liver cirrhosis of any etiology and severity.
You may not qualify if:
- Systemic conditions like:chronic renal failure, diabetes mellitus, thyrotoxicosis, hypothyroidism, Cushing's disease and cancer.
- Local conditions like :Varicocele, urogenital infections, history of cryptorchidism, functional and obstructive azoospermia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Turner HE, Wass JA. Gonadal function in men with chronic illness. Clin Endocrinol (Oxf). 1997 Oct;47(4):379-403. doi: 10.1046/j.1365-2265.1997.2611108.x. No abstract available.
PMID: 9404435BACKGROUNDEshraghian A, Taghavi SA. Systematic review: endocrine abnormalities in patients with liver cirrhosis. Arch Iran Med. 2014 Oct;17(10):713-21.
PMID: 25305772BACKGROUNDKaragiannis A, Harsoulis F. Gonadal dysfunction in systemic diseases. Eur J Endocrinol. 2005 Apr;152(4):501-13. doi: 10.1530/eje.1.01886.
PMID: 15817904BACKGROUNDvan Thiel DH, Gavaler JS, Spero JA, Egler KM, Wright C, Sanghvi AT, Hasiba U, Lewis JH. Patterns of hypothalamic-pituitary-gonadal dysfunction in men with liver disease due to differing etiologies. Hepatology. 1981 Jan-Feb;1(1):39-46. doi: 10.1002/hep.1840010107.
PMID: 6793494BACKGROUNDBannister P, Oakes J, Sheridan P, Losowsky MS. Sex hormone changes in chronic liver disease: a matched study of alcoholic versus non-alcoholic liver disease. Q J Med. 1987 Apr;63(240):305-13.
PMID: 2960998BACKGROUNDSimon-Holtorf J, Monig H, Klomp HJ, Reinecke-Luthge A, Folsch UR, Kloehn S. Expression and distribution of prolactin receptor in normal, fibrotic, and cirrhotic human liver. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):584-9. doi: 10.1055/s-2006-948310.
PMID: 17177141BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 30, 2017
Study Start
January 1, 2018
Primary Completion
January 1, 2019
Study Completion
March 1, 2019
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share