Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones

NCT ID: NCT03167749

Last Updated: 2017-05-30

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

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Male Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients group

Male patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done

Laboratory test

Intervention Type DIAGNOSTIC_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

Laboratory test

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Allam

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dr Emad_eldin Kamal

Role: CONTACT

00201004026100

Dr Ahmad Abdel_mageed

Role: CONTACT

00201001349280

References

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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.

Reference Type BACKGROUND
PMID: 9404435 (View on PubMed)

Eshraghian A, Taghavi SA. Systematic review: endocrine abnormalities in patients with liver cirrhosis. Arch Iran Med. 2014 Oct;17(10):713-21.

Reference Type BACKGROUND
PMID: 25305772 (View on PubMed)

Karagiannis A, Harsoulis F. Gonadal dysfunction in systemic diseases. Eur J Endocrinol. 2005 Apr;152(4):501-13. doi: 10.1530/eje.1.01886.

Reference Type BACKGROUND
PMID: 15817904 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 6793494 (View on PubMed)

Bannister 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.

Reference Type BACKGROUND
PMID: 2960998 (View on PubMed)

Simon-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.

Reference Type BACKGROUND
PMID: 17177141 (View on PubMed)

Other Identifiers

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LcRh

Identifier Type: -

Identifier Source: org_study_id

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