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Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones

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ClinicalTrials.gov Identifier: NCT03167749
Recruitment Status : Unknown
Verified May 2017 by Mohamed Allam, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Allam, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment
Male Infertility Diagnostic Test: Laboratory test

Detailed Description:

Liver is thoroughly involved in proteins, cytokines and interleukins synthesis and destruction. Therefore, abnormal function of endocrine organs is expected in patients with liver cirrhosis.

Hypogonadism is a frequent clinical feature in patients with liver cirrhosis. These patients have gynecomastia, decreased libido, signs of feminization, testicular atrophy and low testosterone level, as well as reduced Spermatogenesis. These features are more severe in patients with higher Child Pugh score.

Several hormonal abnormalities are responsible for these clinical alterations. Estrogen/androgen ratio has been increased in cirrhosis while there is reduction in serum testosterone and dehydroepiandrosterone level.

Hyperprolactinemia is present in patients with cirrhosis and may involve in Hypogonadism by an inhibitory effect on gonadotropins.

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients group
Male patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done
 Diagnostic Test: Laboratory test
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
Control group
Healthy males without history or features of liver disease. Laboratory tests will be done
 Diagnostic Test: Laboratory test
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


Outcome Measures
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Primary Outcome Measures :
  1. Semen parameters (volume, total sperm count and sperm concentration, motility and morphology) [ Time Frame: Baseline ]
    Mean difference in semen parameters(volume, total sperm count and sperm concentration, motility and morphology) between patients and control group

  2. Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone) [ Time Frame: Baseline ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • male patient with liver cirrhosis of any etiology and severity.

Exclusion Criteria:

  1. Systemic conditions like:chronic renal failure, diabetes mellitus, thyrotoxicosis, hypothyroidism, Cushing's disease and cancer.
  2. Local conditions like :Varicocele, urogenital infections, history of cryptorchidism, functional and obstructive azoospermia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167749


Contacts
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Contact: Dr Emad_eldin Kamal 00201004026100 emad@fertility-eg.com
Contact: Dr Ahmad Abdel_mageed 00201001349280 Dr_ahmed1978@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Mohamed Allam, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03167749    
Other Study ID Numbers: LcRh
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Infertility
Infertility, Male
Liver Diseases
Digestive System Diseases