Clinical trial NCT03167749: Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
Official title: Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Male Infertility
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Semen parameters (volume, total sperm count and sperm concentration, motility and morphology)
timeFrame: Baseline
measure: Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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