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Vitamin D and Human Sperm DNA Fragmentation

Effects of Vitamin D on Human Sperm DNA Fragmentation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03829943
Enrollment
230
Registered
2019-02-04
Start date
2019-03-21
Completion date
2022-02-28
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility,Male, Vitamin D Deficiency

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.

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.

Interventions

DIAGNOSTIC_TESTVitamin D

Blood will be drawn for Vitamin D level

Sponsors

Sanford Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to 56 Years

Inclusion criteria

* Male with diagnosis of infertility.

Exclusion criteria

* Azoospermia

Design outcomes

Primary

MeasureTime frameDescription
Sperm DNA Fragmentation1 yearHuman Sperm DNA fragmentation will be determined by the Sperm Chromatin Structure Assay.

Secondary

MeasureTime frameDescription
High DNA stainability1 yearHigh DNA stainability is determined by the Sperm Chromatin Structure Assay and is consistent with immature sperm.
Sperm density1 yearThis will be determined by microscopic analysis of participant's semen and expressed as millions per milliliter

Other

MeasureTime frameDescription
Sperm morphology1 yearThis will be determined by microscopic analysis of participant's semen and will be expressed as percent normal forms.
Height1 yearMeasured by stadiometer and recorded in centimeters.
Race/ethnicity1 yearPatient will self identify race/ethnicity
BMI1 yearweight and height will be combined to report BMI in kg/m\^2
Weight1 yearMeasured using digital, medical scale
Tobacco status1 yearPatient will be asked if uses tobacco products: smoke, smokeless
Sperm motility1 yearThis will be determined by microscopic analysis of participant's semen and expressed as percent motile.

Countries

United States

Contacts

Primary ContactKeith A Hansen, MD
Keith.Hansen@SanfordHealth.org6053288839
Backup ContactAngela Haldeman, RN
Angela.Haldeman@SanfordHealth.org6053288800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026