Serum and Semen Vitamin D Level With Semen Parameters

July 15, 2020 updated by: Mary Yonan, Assiut University

Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • semen analysis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
A year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Younan, Resident, Assiut Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSVDSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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