Lactoferrin and Iron in Seminal Plasma of Varicocele

December 25, 2021 updated by: Marilyn Sameh, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

The patients will be excluded from the group I in the following conditions:

  1. History or evidence of Genital tract infection.
  2. History or evidence of hormonal/chromosomal abnormalities.
  3. History or evidence of chronic debilitating diseases.
  4. History of hormonal treatment or chemotherapy.
  5. Low semen volume less than 1.5 ml.
  6. Severe oligozoospermia less than 5x10*6 /ml.
  7. Azoospermia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
I , Infertile males with varicocele
Lactoferrin , iron in seminal plasma and semen analysis from Infertile patients with varicocele
II , infertile males due to other causes than varicocele
Lactoferrin , iron in seminal plasma and semen analysis from infertile patients due to other causes than varicocele
III , fertile males
Lactoferrin , iron in seminal plasma and semen analysis from fertile males with history of childbirth within the previous year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of lactoferrin and iron in seminal plasma and their possible relation to fertility status in varicocele
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

October 16, 2021

First Submitted That Met QC Criteria

December 25, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 25, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lactoferrin,iron in varicocele

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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