Lactoferrin and Iron in Seminal Plasma of Varicocele

NCT05171504 | Unknown

• 1 other identifier: lactoferrin,iron in varicocele
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Varicocele

Keywords

lactoferrin, iron

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 50 Years
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Collodel G, Signorini C, Nerucci F, Gambera L, Iacoponi F, Moretti E. Semen Biochemical Components in Varicocele, Leukocytospermia, and Idiopathic Infertility. Reprod Sci. 2021 Jan;28(1):91-101. doi: 10.1007/s43032-020-00260-0. Epub 2020 Jul 22.

  PMID: 32696238 BACKGROUND

• Aydemir B, Kiziler AR, Onaran I, Alici B, Ozkara H, Akyolcu MC. Impact of Cu and Fe concentrations on oxidative damage in male infertility. Biol Trace Elem Res. 2006 Sep;112(3):193-203. doi: 10.1385/BTER:112:3:193.

  PMID: 17057258 BACKGROUND

• Kamal HM, El-Fallah AA, Abdelbaki SA, Khalil MM, Kamal MM, Behiry EG. Association between seminal granulysin and malondialdehyde in infertile men with varicocele and the potential effect of varicocelectomy. Andrologia. 2020 Jul;52(6):e13579. doi: 10.1111/and.13579. Epub 2020 Apr 9.

  PMID: 32271478 BACKGROUND

• Kasperczyk A, Dobrakowski M, Czuba ZP, Kapka-Skrzypczak L, Kasperczyk S. Influence of iron on sperm motility and selected oxidative stress parameters in fertile males - a pilot study. Ann Agric Environ Med. 2016 Jun 2;23(2):292-6. doi: 10.5604/12321966.1203893.

  PMID: 27294635 BACKGROUND

• Hao L, Shan Q, Wei J, Ma F, Sun P. Lactoferrin: Major Physiological Functions and Applications. Curr Protein Pept Sci. 2019;20(2):139-144. doi: 10.2174/1389203719666180514150921.

  PMID: 29756573 BACKGROUND

• Buckett WM, Luckas MJ, Gazvani MR, Aird IA, Lewis-Jones DI. Seminal plasma lactoferrin concentrations in normal and abnormal semen samples. J Androl. 1997 May-Jun;18(3):302-4.

  PMID: 9203059 BACKGROUND

• Ammar O, Houas Z, Mehdi M. The association between iron, calcium, and oxidative stress in seminal plasma and sperm quality. Environ Sci Pollut Res Int. 2019 May;26(14):14097-14105. doi: 10.1007/s11356-019-04575-7. Epub 2019 Mar 9.

  PMID: 30852746 BACKGROUND

• Marzec-Wroblewska U, Kaminski P, Lakota P, Szymanski M, Wasilow K, Ludwikowski G, Kuligowska-Prusinska M, Odrowaz-Sypniewska G, Stuczynski T, Michalkiewicz J. Zinc and iron concentration and SOD activity in human semen and seminal plasma. Biol Trace Elem Res. 2011 Oct;143(1):167-77. doi: 10.1007/s12011-010-8868-x. Epub 2010 Oct 6.

  PMID: 20924714 BACKGROUND

• Kikuchi M, Takao Y, Tokuda N, Ohnami Y, Orino K, Watanabe K. Relationship between seminal plasma lactoferrin and gonadal function in horses. J Vet Med Sci. 2003 Nov;65(11):1273-4. doi: 10.1292/jvms.65.1273.

  PMID: 14665762 BACKGROUND

• Gill K, Kups M, Harasny P, Machalowski T, Grabowska M, Lukaszuk M, Matuszewski M, Duchnik E, Fraczek M, Kurpisz M, Piasecka M. The Negative Impact of Varicocele on Basic Semen Parameters, Sperm Nuclear DNA Dispersion and Oxidation-Reduction Potential in Semen. Int J Environ Res Public Health. 2021 Jun 2;18(11):5977. doi: 10.3390/ijerph18115977.

  PMID: 34199549 BACKGROUND

• Hashemi MM, Behnampour N, Nejabat M, Tabandeh A, Ghazi-Moghaddam B, Joshaghani HR. Impact of Seminal Plasma Trace Elements on Human Sperm Motility Parameters. Rom J Intern Med. 2018 Mar 1;56(1):15-20. doi: 10.1515/rjim-2017-0034.

  PMID: 28865234 BACKGROUND

• Kumar N, Singh NK. "Emerging role of Novel Seminal Plasma Bio-markers in Male Infertility: A Review". Eur J Obstet Gynecol Reprod Biol. 2020 Oct;253:170-179. doi: 10.1016/j.ejogrb.2020.08.015. Epub 2020 Aug 24.

  PMID: 32871440 BACKGROUND

• Omes C, De Amici M, Tomasoni V, Todaro F, Torre C, Nappi RE. Myeloperoxidase and lactoferrin expression in semen fluid: Novel markers of male infertility risk? Immunobiology. 2020 Sep;225(5):151999. doi: 10.1016/j.imbio.2020.151999. Epub 2020 Aug 5.

  PMID: 32962819 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

semen

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ali M Mahran, Professor

CONTACT

+201223971344; alimahran74@yahoo.com

Marwa M Mekkawy, Lecturer

CONTACT

+201004899436; marwamekkawy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: December 29, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 29, 2021

Record last verified: 2021-12