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Serum and Semen Vitamin D Level With Semen Parameters

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ClinicalTrials.gov Identifier: NCT03477136
Recruitment Status : Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Yonan, Assiut University

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

Condition or disease Intervention/treatment
Vitamin D Deficiency 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
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: semen analysis




Primary Outcome Measures :
  1. correlation of serum and semen vitamin D level with semen parameters in males [ Time Frame: A year ]
    evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters


Biospecimen Retention:   Samples Without DNA
blood samples semen samples


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

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 -

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): NCT03477136


Contacts
Contact: Emad Kamal, Assistant professor 00201004026100 Emad@fertility-eg.com
Contact: Aya Yousef, Lucturer 00201013244819 Aya_badran@yahoo.com

Locations
Egypt
Faculty of Medicine Not yet recruiting
Assiut, Egypt, 71111
Contact: Rania Mohamed, Professor    01221031572    Rbakry.md@gmail.com   
Principal Investigator: Mary Younan         
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Mary Younan, Resident Assiut Univeristy

Publications:
Responsible Party: Mary Yonan, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03477136     History of Changes
Other Study ID Numbers: SSVDSS
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents