Serum and Semen Vitamin D Level With Semen Parameters

NCT ID: NCT03477136

Last Updated: 2020-07-16

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-06

Study Completion Date

2021-04-30

Brief Summary

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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

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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

Conditions

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Vitamin D Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First group: semen parameter showing normospermic

* 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 .

ELISA to evaluate serum and seminal vitamin D level

Intervention Type DIAGNOSTIC_TEST

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

second group: semen parameter asthenozoospermic

* 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 .

ELISA to evaluate serum and seminal vitamin D level

Intervention Type DIAGNOSTIC_TEST

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

Third group: semen parameter oligozoospermic

* 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 .

ELISA to evaluate serum and seminal vitamin D level

Intervention Type DIAGNOSTIC_TEST

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

Forth groupsemen parameter: astheno-teratozoospermic,

* 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 .

ELISA to evaluate serum and seminal vitamin D level

Intervention Type DIAGNOSTIC_TEST

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

Fifth group semen parameter: oligo asthenoteratozoospermia

* 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 .

ELISA to evaluate serum and seminal vitamin D level

Intervention Type DIAGNOSTIC_TEST

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

Interventions

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ELISA to evaluate serum and seminal vitamin D level

Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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semen analysis

Eligibility Criteria

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Inclusion Criteria

* -males with different semen parameter finding
* Age: 20-50 years

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 -
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mary Yonan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Younan, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut Univeristy

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Blomberg Jensen M, Jorgensen A, Nielsen JE, Bjerrum PJ, Skalkam M, Petersen JH, Egeberg DL, Bangsboll S, Andersen AN, Skakkebaek NE, Juul A, Rajpert-De Meyts E, Dissing S, Leffers H, Jorgensen N. Expression of the vitamin D metabolizing enzyme CYP24A1 at the annulus of human spermatozoa may serve as a novel marker of semen quality. Int J Androl. 2012 Aug;35(4):499-510. doi: 10.1111/j.1365-2605.2012.01256.x. Epub 2012 Mar 9.

Reference Type BACKGROUND
PMID: 22404291 (View on PubMed)

Esteves SC. Clinical relevance of routine semen analysis and controversies surrounding the 2010 World Health Organization criteria for semen examination. Int Braz J Urol. 2014 Jul-Aug;40(4):443-53. doi: 10.1590/S1677-5538.IBJU.2014.04.02.

Reference Type BACKGROUND
PMID: 25254609 (View on PubMed)

Hammoud AO, Meikle AW, Peterson CM, Stanford J, Gibson M, Carrell DT. Association of 25-hydroxy-vitamin D levels with semen and hormonal parameters. Asian J Androl. 2012 Nov;14(6):855-9. doi: 10.1038/aja.2012.77. Epub 2012 Oct 8.

Reference Type BACKGROUND
PMID: 23042450 (View on PubMed)

Herrmann M, Farrell CL, Pusceddu I, Fabregat-Cabello N, Cavalier E. Assessment of vitamin D status - a changing landscape. Clin Chem Lab Med. 2017 Jan 1;55(1):3-26. doi: 10.1515/cclm-2016-0264.

Reference Type BACKGROUND
PMID: 27362963 (View on PubMed)

Yan WJ, Yu N, Yin TL, Liu L, Yang J. Can Vitamin D supplementation be used as adjunctive treatment for oligozoospermia or asthenozoospermia accompanied with Vitamin D deficiency? Asian J Androl. 2015 Jan-Feb;17(1):165-7. doi: 10.4103/1008-682X.138190. No abstract available.

Reference Type BACKGROUND
PMID: 25219916 (View on PubMed)

Other Identifiers

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SSVDSS

Identifier Type: -

Identifier Source: org_study_id

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