NCT03477136

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

December 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

March 20, 2018

Last Update Submit

July 15, 2020

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • correlation of serum and semen vitamin D level with semen parameters in males

    evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters

    A year

Study Arms (5)

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

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

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

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

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

Interventions

ELISA to evaluate serum and seminal vitamin D levelDIAGNOSTIC_TEST

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

Also known as: semen analysis
Fifth group semen parameter: oligo asthenoteratozoospermiaFirst group: semen parameter showing normospermicForth groupsemen parameter: astheno-teratozoospermic,Third group: semen parameter oligozoospermicsecond group: semen parameter asthenozoospermic

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • males with different semen parameter finding
  • Age: 20-50 years

You may not qualify if:

  • Varicocele.
  • Genital tract infections.
  • Primary and secondary hypogonadism
  • Hormonal therapy.
  • Calcium and vitamin D supplement.
  • Hepatic or renal failure
  • Diseases or drugs affecting vitamin D absorption -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71111, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 22404291BACKGROUND

  • 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.

    PMID: 25254609BACKGROUND

  • 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.

    PMID: 23042450BACKGROUND

  • 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.

    PMID: 27362963BACKGROUND

  • 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.

    PMID: 25219916BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples semen samples

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Semen Analysis

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Mary Younan, Resident

    Assiut Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 26, 2018

Study Start

December 6, 2018

Primary Completion

July 13, 2020

Study Completion

April 1, 2021

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

EG(1)