Vitamin D Level vs Semen Parameters

NCT03167008 | Unknown

• 1 other identifier: VDSP
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Male Infertility

Outcome Measures

Primary Outcomes (1)

• correlation between vitamin D level and semen parameters

  baseline

Study Arms (2)

idiopathic male infertility

* total of 30 male patients with idiopathic male infertility. * 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 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.

Diagnostic Test: semen sample; Diagnostic Test: blood sample

fertile male group

* total of 30 fertile male (as control) * Semen samples will be collected,Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010). * 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.

Diagnostic Test: semen sample; Diagnostic Test: blood sample

Interventions

semen sample DIAGNOSTIC_TEST

-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)

fertile male group; idiopathic male infertility

blood sample DIAGNOSTIC_TEST

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

fertile male group; idiopathic male infertility

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

total of 30 male patients with idiopathic male infertility and other 30 fertile male (as control) will be randomly recruited from the outpatient andrology clinic of the department at Assiut university hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Irvine DS. Epidemiology and aetiology of male infertility. Hum Reprod. 1998 Apr;13 Suppl 1:33-44. doi: 10.1093/humrep/13.suppl_1.33.

  PMID: 9663768 BACKGROUND

• 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. doi: 10.1093/humrep/deh870. Epub 2005 Mar 31.

  PMID: 15802321 BACKGROUND

• 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.

  PMID: 22264467 BACKGROUND

• Blomberg Jensen M, Nielsen JE, Jorgensen A, Rajpert-De Meyts E, Kristensen DM, Jorgensen 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.

  PMID: 20172873 BACKGROUND

• 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. doi: 10.1210/endo-114-6-2167.

  PMID: 6327237 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• MAKhair

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Ali Mohamed Mahran

CONTACT

00201223971344; alimahran74@yahoo.com

Dr Doaa Ahmed Elsyed Aboutaleb

CONTACT

00201001463937; Dodda_aboutaleb@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: October 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: August 4, 2020

Record last verified: 2020-08