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Trial record 4 of 4 for:    vitamin D male infertility
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Vitamin D and Human Sperm DNA Fragmentation

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ClinicalTrials.gov Identifier: NCT03829943
Recruitment Status : Unknown
Verified October 2020 by Keith Hansen, Sanford Health.
Recruitment status was:  Recruiting
First Posted : February 4, 2019
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Keith Hansen, Sanford Health

Study Description
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Brief Summary:
The purpose of this study will be to investigate if there is a correlation between Vitamin D levels and Sperm DNA Fragmentation. This is a prospective, cohort study. In this study male participants presenting with their partners because of inability to conceive will be recruited for this study. Participants will have a blood sample drawn which will be tested for Vitamin D level. The investigators will then compare sperm DNA fragmentation between normal Vitamin D levels, Vitamin D insufficiency, and Vitamin D deficiency. All infertile males who present to the investigators' infertility clinic have a Semen analysis and Sperm chromatin Structure Assay (SCSA). The research part of the study will be to obtain the Vitamin D level.

Condition or disease Intervention/treatment
Infertility,Male Vitamin D Deficiency Diagnostic Test: Vitamin D

Detailed Description:

Vitamin D plays an important role in bone metabolism and has also been discovered to influence male reproduction. Vitamin D binds to the Vitamin D receptor which then can bind to Vitamin D response elements in the DNA which can alter transcription. By changing transcription it can have long term effects on cellular metabolism. Previous studies have demonstrated abnormalities in sperm motility and morphology in males who are Vitamin D deficient. The mechanism by which Vitamin D affects spermatogenesis (formation of sperm) is unknown. One possibly mechanism by which deficient Vitamin D may affect sperm formation is through DNA fragmentation. The head of the sperm contains all the DNA. When a sperm cell is made the DNA in the nucleus must be super compacted to accomplish sperm formation. To sufficiently compact the DNA, first the DNA is 'turned off' and then very tightly wound (or compacted) into toroids (like small tires) which are stacked one on top of another. During this process of compaction the DNA will occasionally break or fragment. The egg can repair the DNA fragmentation as long as there is not a large amount of breakage. If the DNA fragmentation exceeds a certain amount then fertilization and early development of the embryo may be adversely affected. DNA fragmentation can be tested by using the Sperm Chromatin Structure Assay (SCSA), which the investigators currently measure in males who present with their partners with infertility. Previous studies have suggested that the abnormalities in sperm due to vitamin D deficiency may be related to increased DNA fragmentation. This study will assist in understanding the cause of sperm abnormalities in subjects with Vitamin D deficiency.

This is a prospective, cohort study. In this study male patients who present with inability to conceive will be asked to be involved in this study. After agreement with the study, a blood sample drawn which will be tested for Vitamin D level. The investigators will then compare sperm DNA fragmentation between normal Vitamin D levels, Vitamin D insufficiency, and Vitamin D deficiency. All infertile males presenting to the investigators' infertility clinic have a Semen analysis and Sperm chromatin Structure Assay (SCSA). The research part of the study will be to obtain the Vitamin D level.

Study Design
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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Vitamin D on Human Sperm DNA Fragmentation
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Vitamin D deficiency
The study group will be males discovered to have Vitamin D deficiency.
 Diagnostic Test: Vitamin D
Blood will be drawn for Vitamin D level
Control group
The control group will be males with normal Vitamin D status
 Diagnostic Test: Vitamin D
Blood will be drawn for Vitamin D level


Outcome Measures
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Primary Outcome Measures :
  1. Sperm DNA Fragmentation [ Time Frame: 1 year ]
    Human Sperm DNA fragmentation will be determined by the Sperm Chromatin Structure Assay.


Secondary Outcome Measures :
  1. High DNA stainability [ Time Frame: 1 year ]
    High DNA stainability is determined by the Sperm Chromatin Structure Assay and is consistent with immature sperm.

  2. Sperm density [ Time Frame: 1 year ]
    This will be determined by microscopic analysis of participant's semen and expressed as millions per milliliter


Other Outcome Measures:
  1. Sperm motility [ Time Frame: 1 year ]
    This will be determined by microscopic analysis of participant's semen and expressed as percent motile.

  2. Sperm morphology [ Time Frame: 1 year ]
    This will be determined by microscopic analysis of participant's semen and will be expressed as percent normal forms.

  3. Height [ Time Frame: 1 year ]
    Measured by stadiometer and recorded in centimeters.

  4. Weight [ Time Frame: 1 year ]
    Measured using digital, medical scale

  5. BMI [ Time Frame: 1 year ]
    weight and height will be combined to report BMI in kg/m^2

  6. Tobacco status [ Time Frame: 1 year ]
    Patient will be asked if uses tobacco products: smoke, smokeless

  7. Race/ethnicity [ Time Frame: 1 year ]
    Patient will self identify race/ethnicity


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 56 Years   (Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
Male partners of infertile couples. All males who present to our Infertility clinic will be offered participation.
Criteria

Inclusion Criteria:

  • Male with diagnosis of infertility.

Exclusion Criteria:

  • Azoospermia
Contacts and Locations
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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): NCT03829943


Contacts
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Contact: Keith A Hansen, MD 6053288839 Keith.Hansen@SanfordHealth.org
Contact: Angela Haldeman, RN 6053288800 Angela.Haldeman@SanfordHealth.org

Locations
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United States, South Dakota
Sanford Health Fertility and Reproductive Medicine Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Keith Hansen, MD    605-328-8829    keith.hansen@sanfordhealth.org   
Contact: Angela Haldeman, RN    605-328-8800    angela.haldeman@sanfordhealth.org   
Sponsors and Collaborators
Sanford Health
More Information
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Publications:

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Responsible Party: Keith Hansen, Principal Investigator, Sanford Health
ClinicalTrials.gov Identifier: NCT03829943    
Other Study ID Numbers: MOD00002311
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share individual participant data (IPD) with researchers who desire information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be available after collection complete and will remain available for 3 years.
Access Criteria: Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents