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临床试验/NCT05171504
NCT05171504Unknown不适用

Detection of Lactoferrin and Iron in Seminal Plasma and Their Possible Relation to Fertility Status in Varicocele: A Case-control Study

Assiut University0 个研究点目标入组 75 人开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
主要终点
Detection of lactoferrin and iron in seminal plasma and their possible relation to fertility status in varicocele

研究概览

简要总结

Infertility is defined by World Health Organization (WHO) as a disease of reproductive system characterized by failure to achieve clinical pregnancy even after 12 months or more of regular unprotected sexual intercourse. It affects around 15% of all couples, that is 48.5 million couples worldwide.

Male infertility has emerged as an important cause of infertility worldwide. There are many factors affecting male fertility and research is going on to know impact of various factors on sperm functions.Male infertility affects 30:40% of cases.

Infertility could be due to different aetiologies. Among the possible causes are genetic factors, obstructive disorders (congenital absence of vas deferens), varicocele and testicular dysgenesis. However, some cases of male infertility are idiopathic.

详细描述

Varicocele is considered as the second most common cause of infertility. In the general population, approximately 15% of adult men have varicocele, but in the population of infertile men, the prevalence rises to 40% of cases with primary infertility and 80% in secondary infertility .

Varicocele is characterised by dilated veins of the pampiniform plexus which are responsible for the testicular blood drainage.Varicocele can affect fertility through hypoxia of the testicular tissues, germ cell apoptosis, oxidative stress, reflux of toxic metabolites from the renal/adrenal tissues and hyperthermia of the testis.

Semen analysis is the gold standard diagnostic test for male infertility. Seminal plasma is considered a gold mine for male fertility as it contains molecules from male reproductive glands which play important role in sperm function.

Lactoferrin is an iron-binding globular glycoprotein that act as immunomodulator mainly at mucosal level. In general, lactoferrin plays important role in the regulation of iron absorption, the modulation of immune responses, and has anti-microbial, anti-viral, antioxidant, anticancer, and anti-inflammatory activities.

Lactoferrin is found in various exocrine fluids and blood plasma. It is secreted from the prostate and seminal vesicles in humans. The physiological role of the lactoferrin in the male reproductive tract remains unclear.

研究设计

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Group I will include infertile patients with varicocele that is diagnosed clinically and by doppler scrotal ultrasonography.
  • Group II will include infertile patients due to other causes than varicocele
  • Group III will include fertile men with history of childbirth within the previous year.

排除标准

  • The patients will be excluded from the group I in the following conditions:
  • History or evidence of Genital tract infection.
  • History or evidence of hormonal/chromosomal abnormalities.
  • History or evidence of chronic debilitating diseases.
  • History of hormonal treatment or chemotherapy.
  • Low semen volume less than 1.5 ml.
  • Severe oligozoospermia less than 5x10*6 /ml.
  • Azoospermia.

结局指标

主要结局

Detection of lactoferrin and iron in seminal plasma and their possible relation to fertility status in varicocele

时间窗: 6 months

Correlation of the level of lactoferrin and iron in seminal plasma with semen parameters in infertile patients with varicocele , infertile patients due to other causes than varicocele and fertile men. Evaluation the level of lactoferrin in seminal plasma by using ELISA method and the level of iron in seminal plasma by semiautomated colorimetric method.

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

Marilyn Sameh

Principle investigator

Assiut University

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