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临床试验/NCT03167749
NCT03167749Unknown不适用

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

Assiut University0 个研究点目标入组 90 人开始时间: 2018年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)

时间窗: 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

Semen parameters (volume, total sperm count and sperm concentration, motility and morphology)

时间窗: Baseline

Mean difference in semen parameters(volume, total sperm count and sperm concentration, motility and morphology) between patients and control group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Allam

Principal investigator

Assiut University

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