Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones

Male Infertility Clinical Trial

Official title:

Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03167749
• Other study ID #: LcRh
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 24, 2017
• Start date: January 2018
• Est. completion date: March 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Dr Emad_eldin Kamal
• Phone: 00201004026100
• Email: emad[@]fertility-eg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Liver Cirrhosis
• Male Infertility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

Eshraghian A, Taghavi SA. Systematic review: endocrine abnormalities in patients with liver cirrhosis. Arch Iran Med. 2014 Oct;17(10):713-21. doi: 0141710/AIM.0013. Review. — View Citation

Karagiannis A, Harsoulis F. Gonadal dysfunction in systemic diseases. Eur J Endocrinol. 2005 Apr;152(4):501-13. Review. — View Citation

Simon-Holtorf J, Mönig H, Klomp HJ, Reinecke-Lüthge A, Fölsch 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. — View Citation

Turner HE, Wass JA. Gonadal function in men with chronic illness. Clin Endocrinol (Oxf). 1997 Oct;47(4):379-403. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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