An observational study in Varicocele, sponsored by Assiut University. Status unknown. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Assiut University · Observational
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.
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.
Few studies have investigated the effect of lactoferrin on semen quality in humans. A recent study has demonstrated that lactoferrin expression on cells of seminal fluid was associated with worse sperm concentration and morphology, considering it as a possible novel marker of male infertility. Other studies showed that seminal lactoferrin concentrations were raised in patient groups with oligozoospermia and oligoasthenozoospermia.
Iron is an essential trace nutrient that plays an important role in general health and fertility. It is not essentially toxic, but disturbances can appear due to prolonged intake of high doses or dysfunction in the regulatory mechanism.
Iron is one of the trace elements that present in semen.It participates in oxygenation and reduction processes, entering into the composition of many enzymes and metalloprotein compounds. It has been reported that iron can cause an increase in sperm damage.
The toxicity of iron could result from the formation of hydroxyl free radicals. Iron-induced oxidative stress may induce lipid peroxidation, which has been shown to result in deterioration of sperm morphology and motility. So, iron is highly toxic if accumulated in large quantities. Also,the excess or deficiency may lead to defective spermatogenesis and to fertility impairment.
Most of the previous researches on the effect of iron on sperm function have shown increased level of seminal iron in sub-fertile than fertile men. In addition, significant higher concentrations of seminal iron were detected in asthenozoospermic and teratozoospermic groups.
On the contrary, a study has demonstrated that iron level and other trace elements were significantly lower in seminal fluid of asthenozoospermic subjects in comparison with normozoospermic men. In that study, although higher levels of iron were detected in men with normal semen analysis, these higher levels adversely affected sperm motility in this group.
53 studies on the registry are indexed under Varicocele; 15 are open to participants now.
This study's planned enrollment of 75 is below the median of 119 across 17 observational studies indexed under Varicocele.
Browse Varicocele studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The participants will be divided in to three equal groups:
Group I: will include 25 patients with varicocele seeking medical advice for infertility.
Group II: will include 25 patients seeking medical advice for infertility due to other causes than varicocele as a control group.
Group III: will include 25 fertile male participants as a control group.
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Exclusion Criteria:
The patients will be excluded from the group I in the following conditions:
Lactoferrin , iron in seminal plasma and semen analysis from Infertile patients with varicocele
Lactoferrin , iron in seminal plasma and semen analysis from infertile patients due to other causes than varicocele
Lactoferrin , iron in seminal plasma and semen analysis from fertile males with history of childbirth within the previous year
Detection of lactoferrin and iron in seminal plasma and their possible relation to fertility status in varicocele
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.
Time frame: 6 months
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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