Serum and Semen Vitamin D Level With Semen Parameters

• Conditions: Vitamin D Deficiency
• Interventions: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level

• Registration Number: NCT03477136
• Lead Sponsor: Assiut University

Brief Summary

vitamin D may have multiple functions, one of them is modulating reproductive processes and the reproductive role of vitamin D is highlighted by expression of the vitamin D receptors in testis, male reproductive tract and sperms

Detailed Description

Semen analysis is the corner stone of infertility evaluation as it provides information on the functional status of the seminiferous tubules, epididymis and accessory sex glands. The methods on how the semen should be evaluated are provided by the World Health Organization Vitamin D is synthesized mainly in the skin, where ultraviolet ray B radiation converts 7-dehydrocholesterol to Vitamin D3. Then, Vitamin D3 undergoes two hydroxylation processes first in the liver and second in the kidney Serum 25(OH)D is the major circulating metabolite of vitamin D and reflects vitamin D inputs from cutaneous synthesis and dietary intake. The serum 25(OH)D level is the standard clinical measure of vitamin D status Vitamin D deficiency has been linked to various health disorders including boneheallth, cardiovascular, infectious, oncologic, musculoskeletal, neuropsychologic and reproductive disorders, as well as to overall mortality

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-26
• Study Start: 2018-12-06
• Status Verified: 2020-07
• Primary Completion: 2020-07-13
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Varicocele.
2. Genital tract infections.
3. Primary and secondary hypogonadism
4. Hormonal therapy.
5. Calcium and vitamin D supplement.
6. Hepatic or renal failure
7. Diseases or drugs affecting vitamin D absorption -

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
second group: semen parameter asthenozoospermic	ELISA to evaluate serum and seminal vitamin D level	* group will include 30 male * 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 and semen sample will be collected from all males to evaluate vitamin D level by ELISA .
Third group: semen parameter oligozoospermic	ELISA to evaluate serum and seminal vitamin D level	* group will include 30 male * 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 and semen sample will be collected from all males to evaluate vitamin D level by ELISA .
Fifth group semen parameter: oligo asthenoteratozoospermia	ELISA to evaluate serum and seminal vitamin D level	* group will include 30 male * 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 and semen sample will be collected from all males to evaluate vitamin D level by ELISA .
First group: semen parameter showing normospermic	ELISA to evaluate serum and seminal vitamin D level	* group will include 30 male * 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 and semen sample will be collected from all males to evaluate vitamin D level by ELISA .
Forth groupsemen parameter: astheno-teratozoospermic,	ELISA to evaluate serum and seminal vitamin D level	* group will include 30 male * 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 and semen sample will be collected from all males to evaluate vitamin D level by ELISA .

Primary Outcome Measures

Name	Time	Method
correlation of serum and semen vitamin D level with semen parameters in males	A year	evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt