Vitamin D Level vs Semen Parameters

• Conditions: Male Infertility
• Interventions: Diagnostic Test: semen sample; Diagnostic Test: blood sample

• Registration Number: NCT03167008
• Lead Sponsor: Assiut University

Brief 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.

* 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-01
• Last Update Posted: 2020-08-04
• Study Start: 2020-10
• Primary Completion: 2021-02
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
idiopathic male infertility	semen 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	semen 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.
idiopathic male infertility	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	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.

Primary Outcome Measures

Name	Time	Method
correlation between vitamin D level and semen parameters	baseline