VaricoceleNCT05171504
Lactoferrin and Iron in Seminal Plasma of Varicocele
An observational study of Varicocele, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Varicocele
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicocele
- Keywords
- lactoferrin, iron
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Sameh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171504
- Sponsor's protocol ID
- lactoferrin,iron in varicocele
- Status last verified
- Dec 2021
- First submitted
- 16 Oct 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32696238Aydemir 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.
PubMed 17057258Kamal 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.
PubMed 32271478Kasperczyk 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.
PubMed 27294635Hao 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.
PubMed 29756573Buckett 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.
PubMed 9203059Ammar 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.
PubMed 30852746Marzec-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.
PubMed 20924714Kikuchi 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.
PubMed 14665762Gill 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.
PubMed 34199549Hashemi 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.
PubMed 28865234Kumar 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.
PubMed 32871440Omes 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.
PubMed 32962819
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Lactoferrin and Iron in Seminal Plasma and Their Possible Relation to Fertility Status in Varicocele: A Case-control Study
- ClinicalTrials.gov ID
- NCT05171504
- Acronym / sponsor ID
- lactoferrin,iron in varicocele
- Conditions
- Varicocele
- Keywords
- lactoferrin, iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Background: PubMed 32696238Collodel 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.
- Background: PubMed 17057258Aydemir 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.
- Background: PubMed 32271478Kamal 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.
- Background: PubMed 27294635Kasperczyk 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.
- Background: PubMed 29756573Hao 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.
- Background: PubMed 9203059Buckett 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.
- Background: PubMed 30852746Ammar 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.
- Background: PubMed 20924714Marzec-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.
- Background: PubMed 14665762Kikuchi 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.
- Background: PubMed 34199549Gill 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.
- Background: PubMed 28865234Hashemi 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.
- Background: PubMed 32871440Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali M Mahran, Professor (+201223971344, alimahran74@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of lactoferrin and iron in seminal plasma and their possible relation to fertility status in varicocele (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171504, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.