Clinical trial NCT03477136: Serum and Semen Vitamin D Level With Semen Parameters
Official title: Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 150
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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 -

Primary outcomes:
measure: correlation of serum and semen vitamin D level with semen parameters in males
timeFrame: A year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Assiut Univeristy
name: Mary Younan, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.