Vitamin D Level vs Semen Parameters

Male Infertility Clinical Trial

Official title:

Correlation Between the Level of Vitamin D and Semen Parameters

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03167008
• Other study ID #: VDSP
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: March 2021

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: Dr Ali Mohamed Mahran
• Phone: 00201223971344
• Email: alimahran74[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Diagnostic Test:
• semen sample
-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 sample
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Blomberg Jensen M, Nielsen JE, Jørgensen A, Rajpert-De Meyts E, Kristensen DM, Jørgensen N, Skakkebaek NE, Juul A, Leffers H. Vitamin D receptor and vitamin D metabolizing enzymes are expressed in the human male reproductive tract. Hum Reprod. 2010 May;25(5):1303-11. doi: 10.1093/humrep/deq024. Epub 2010 Feb 18. — View Citation

Gnoth C, Godehardt E, Frank-Herrmann P, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod. 2005 May;20(5):1144-7. Epub 2005 Mar 31. Review. — View Citation

Irvine DS. Epidemiology and aetiology of male infertility. Hum Reprod. 1998 Apr;13 Suppl 1:33-44. Review. — View Citation

Ko EY, Siddiqi K, Brannigan RE, Sabanegh ES Jr. Empirical medical therapy for idiopathic male infertility: a survey of the American Urological Association. J Urol. 2012 Mar;187(3):973-8. doi: 10.1016/j.juro.2011.10.137. Epub 2012 Jan 20. — View Citation

Walters MR. 1,25-dihydroxyvitamin D3 receptors in the seminiferous tubules of the rat testis increase at puberty. Endocrinology. 1984 Jun;114(6):2167-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between vitamin D level and semen parameters		baseline