Vitamin D Level vs Semen Parameters

NCT ID: NCT03167008

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-03-31

Brief Summary

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* 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

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-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

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Male Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

semen sample

Intervention Type DIAGNOSTIC_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 sample

Intervention Type DIAGNOSTIC_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

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.

semen sample

Intervention Type DIAGNOSTIC_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 sample

Intervention Type DIAGNOSTIC_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

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

blood sample

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* infertile male patients without any detectable cause with normal clinical examination and abnormal semen parameters.

Exclusion Criteria

* 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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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kh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MAKhair

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Dr Ali Mohamed Mahran

Role: CONTACT

00201223971344

Dr Doaa Ahmed Elsyed Aboutaleb

Role: CONTACT

00201001463937

References

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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.

Reference Type BACKGROUND
PMID: 9663768 (View on PubMed)

Gnoth 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.

Reference Type BACKGROUND
PMID: 15802321 (View on PubMed)

Ko 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.

Reference Type BACKGROUND
PMID: 22264467 (View on PubMed)

Blomberg 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.

Reference Type BACKGROUND
PMID: 20172873 (View on PubMed)

Walters 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.

Reference Type BACKGROUND
PMID: 6327237 (View on PubMed)

Other Identifiers

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VDSP

Identifier Type: -

Identifier Source: org_study_id

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