Serum and Semen Vitamin D Level With Semen Parameters

Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males

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

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Diagnostic test: ELISA to evaluate serum and seminal vitamin D level

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

The patients will be recruited from the out patient clinic of Andrology, Assuit university hospital.

One hundred and fifty individuals will be included divided into five groups according to semen parameters finding

Description

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 .	Diagnostic test: 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; Other Names: semen analysis
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 .	Diagnostic test: 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; Other Names: semen analysis
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 .	Diagnostic test: 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; Other Names: semen analysis
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 .	Diagnostic test: 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; Other Names: semen analysis
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 .	Diagnostic test: 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; Other Names: semen analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation of serum and semen vitamin D level with semen parameters in males	evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters	A year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mary Younan, Resident, Assiut Univeristy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): July 13, 2020
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: SSVDSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No