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Vitamin D Level vs Semen Parameters

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ClinicalTrials.gov Identifier: NCT03167008
Recruitment Status : Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
kh, Assiut University

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.

Condition or disease Intervention/treatment
Male Infertility Diagnostic Test: semen sample Diagnostic Test: blood sample

Detailed 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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Correlation Between the Level of Vitamin D and Semen Parameters
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Group/Cohort Intervention/treatment
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
-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)

Diagnostic Test: 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

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
-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)

Diagnostic Test: 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




Primary Outcome Measures :
  1. correlation between vitamin D level and semen parameters [ Time Frame: baseline ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167008


Contacts
Contact: Dr Ali Mohamed Mahran 00201223971344 alimahran74@yahoo.com
Contact: Dr Doaa Ahmed Elsyed Aboutaleb 00201001463937 Dodda_aboutaleb@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: MAKhair Assiut University

Publications:
Responsible Party: kh, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03167008     History of Changes
Other Study ID Numbers: VDSP
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Vitamins
Vitamin D
Ergocalciferols
Hormones
Testosterone
Follicle Stimulating Hormone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Androgens