Male InfertilityNCT03167008
Vitamin D Level vs Semen Parameters
An observational study of Male Infertility, run by Assiut University.
Trial summary
Infertility is defined as the inability of a sexually active couple to conceive after 1 year of regular intercourse without contraception, affects approximately 15% of couples, and male factors are the cause in 20% -50% of cases. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- semen sample and blood sample
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Mar 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: total of 30 male patients with idiopathic male infertility and other 30 fertile male (as control) will be randomly recruited from the outpatient andrology clinic of the department at Assiut university hospital.
Who may be able to join
- infertile male patients without any detectable cause with normal clinical examination and abnormal semen parameters.
Who cannot join
- Cases with known etiology or apparent physical finding ,leukocytospermia, diminished testicular volume ,varicocele or an abnormal hormonal profile.
- couples with combined male and female factor will be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correlation Between the Level of Vitamin D and Semen Parameters
- Infertility is defined as the inability of a sexually active couple to conceive after 1 year of regular intercourse without contraception, affects approximately 15% of couples, and male factors are the cause in 20% -50% of cases.
- Infertility of unknown origin is classified into idiopathic male infertility and unexplained male infertility according to semen quality.
Read the detailed description
-Idiopathic male infertility is known as idiopathic oligoasthenoteratozoospermia, which indicates that the men have an unexplained reduction of semen quality.
In contrast, unexplained male infertility is defined as infertility of unknown origin with normal sperm parameters.
Furthermore, optimal strategies for treating idiopathic male infertility have also remained unclear.
- Data from studies in humans suggest that vitamin D receptors are present in testis, epididymis, prostate and seminal vesicles. The level of expression varies, being higher in epididymis and seminal vesicles.
- Vitamin D receptors expression was also evident in Leydig cells, as well as in normal and abnormal sperm, with the acrosomal region and the neck being the sites with the most abundant messenger ribonucleic acid expression.
- The 1,25(OH)2 D3 molecule increases intracellular calcium concentrations, sperm motility and acrosin activity, and reduces triglyceride content in sperm, actions that significantly contribute to fertilising capacity within the female reproductive tract.
- Conditions
- Male Infertility
- Being tested
- semen sample, blood sample
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen sampleDiagnostic test
-Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
blood sampleDiagnostic test
blood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured
| Study group | Role | What they receive |
|---|---|---|
| idiopathic male infertility | * total of 30 male patients with idiopathic male infertility.
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010).
* blood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured. Receives: Diagnostic Test: semen sample; Diagnostic Test: blood sample | |
| fertile male group | * total of 30 fertile male (as control)
* Semen samples will be collected,Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010).
* blood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured. Receives: Diagnostic Test: semen sample; Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between vitamin D level and semen parameters
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startOct 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kh, Assiut University
- Investigators
- MAKhair, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167008
- Sponsor's protocol ID
- VDSP
- Status last verified
- Aug 2020
- First submitted
- 23 May 2017
- Last updated
- 4 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Irvine DS. Epidemiology and aetiology of male infertility. Hum Reprod. 1998 Apr;13 Suppl 1:33-44. doi: 10.1093/humrep/13.suppl_1.33.
PubMed 9663768Gnoth C, Godehardt E, Frank-Herrmann P, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod. 2005 May;20(5):1144-7. doi: 10.1093/humrep/deh870. Epub 2005 Mar 31.
PubMed 15802321Ko EY, Siddiqi K, Brannigan RE, Sabanegh ES Jr. Empirical medical therapy for idiopathic male infertility: a survey of the American Urological Association. J Urol. 2012 Mar;187(3):973-8. doi: 10.1016/j.juro.2011.10.137. Epub 2012 Jan 20.
PubMed 22264467Blomberg Jensen M, Nielsen JE, Jorgensen A, Rajpert-De Meyts E, Kristensen DM, Jorgensen N, Skakkebaek NE, Juul A, Leffers H. Vitamin D receptor and vitamin D metabolizing enzymes are expressed in the human male reproductive tract. Hum Reprod. 2010 May;25(5):1303-11. doi: 10.1093/humrep/deq024. Epub 2010 Feb 18.
PubMed 20172873Walters MR. 1,25-dihydroxyvitamin D3 receptors in the seminiferous tubules of the rat testis increase at puberty. Endocrinology. 1984 Jun;114(6):2167-74. doi: 10.1210/endo-114-6-2167.
PubMed 6327237
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Level of Vitamin D and Semen Parameters
- ClinicalTrials.gov ID
- NCT03167008
- Acronym / sponsor ID
- VDSP
- Conditions
- Male Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 25 May 2017 (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 as the inability of a sexually active couple to conceive after 1 year of regular intercourse without contraception, affects approximately 15% of couples, and male factors are the cause in 20% -50% of cases.
- Infertility of unknown origin is classified into idiopathic male infertility and unexplained male infertility according to semen quality.
Detailed description
-Idiopathic male infertility is known as idiopathic oligoasthenoteratozoospermia, which indicates that the men have an unexplained reduction of semen quality.
In contrast, unexplained male infertility is defined as infertility of unknown origin with normal sperm parameters.
Furthermore, optimal strategies for treating idiopathic male infertility have also remained unclear.
- Data from studies in humans suggest that vitamin D receptors are present in testis, epididymis, prostate and seminal vesicles. The level of expression varies, being higher in epididymis and seminal vesicles.
- Vitamin D receptors expression was also evident in Leydig cells, as well as in normal and abnormal sperm, with the acrosomal region and the neck being the sites with the most abundant messenger ribonucleic acid expression.
- The 1,25(OH)2 D3 molecule increases intracellular calcium concentrations, sperm motility and acrosin activity, and reduces triglyceride content in sperm, actions that significantly contribute to fertilising capacity within the female reproductive tract.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| idiopathic male infertility | – | Diagnostic Test: semen sample, Diagnostic Test: blood sample* total of 30 male patients with idiopathic male infertility. * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010). * blood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured. |
| fertile male group | – | Diagnostic Test: semen sample, Diagnostic Test: blood sample* total of 30 fertile male (as control) * Semen samples will be collected,Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010). * blood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- total of 30 male patients with idiopathic male infertility and other 30 fertile male (as control) will be randomly recruited from the outpatient andrology clinic of the department at Assiut university hospital.
Key inclusion criteria (1 listed)
- infertile male patients without any detectable cause with normal clinical examination and abnormal semen parameters.
Key exclusion criteria (2 listed)
- Cases with known etiology or apparent physical finding ,leukocytospermia, diminished testicular volume ,varicocele or an abnormal hormonal profile.
- couples with combined male and female factor will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semen sample-Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) | Diagnostic test | fertile male group, idiopathic male infertility |
| blood sampleblood samples will be taken \&the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured | Diagnostic test | fertile male group, idiopathic male infertility |
Primary outcome
correlation between vitamin D level and semen parameters
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 9663768Irvine DS. Epidemiology and aetiology of male infertility. Hum Reprod. 1998 Apr;13 Suppl 1:33-44. doi: 10.1093/humrep/13.suppl_1.33.
- Background: PubMed 15802321Gnoth C, Godehardt E, Frank-Herrmann P, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod. 2005 May;20(5):1144-7. doi: 10.1093/humrep/deh870. Epub 2005 Mar 31.
- Background: PubMed 22264467Ko EY, Siddiqi K, Brannigan RE, Sabanegh ES Jr. Empirical medical therapy for idiopathic male infertility: a survey of the American Urological Association. J Urol. 2012 Mar;187(3):973-8. doi: 10.1016/j.juro.2011.10.137. Epub 2012 Jan 20.
- Background: PubMed 20172873Blomberg Jensen M, Nielsen JE, Jorgensen A, Rajpert-De Meyts E, Kristensen DM, Jorgensen N, Skakkebaek NE, Juul A, Leffers H. Vitamin D receptor and vitamin D metabolizing enzymes are expressed in the human male reproductive tract. Hum Reprod. 2010 May;25(5):1303-11. doi: 10.1093/humrep/deq024. Epub 2010 Feb 18.
- Background: PubMed 6327237Walters MR. 1,25-dihydroxyvitamin D3 receptors in the seminiferous tubules of the rat testis increase at puberty. Endocrinology. 1984 Jun;114(6):2167-74. doi: 10.1210/endo-114-6-2167.
Related trials for Male Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
Active, not recruiting
YO® Smartphone Home Sperm Test Versus Manual Semen Analysis in Egyptian Men
Semen Analysis, Male Infertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
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.
MAKhair principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, 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 1 inclusion and 2 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 4 Aug 2020. 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 Dr Ali Mohamed Mahran (00201223971344, alimahran74@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between vitamin D level and semen parameters (time frame: baseline). 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 NCT03167008, which also lists 5 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 4 Aug 2020.