Vitamin D and Human Sperm DNA Fragmentation

Vitamin D Deficiency Clinical Trial

Official title:

Effects of Vitamin D on Human Sperm DNA Fragmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03829943
• Other study ID #: MOD00002311
• Status: Recruiting
• Start date: March 21, 2019
• Est. completion date: February 2022

Study information

• Verified date: October 2020
• Source: Sanford Health
• Contact: Keith A Hansen, MD
• Phone: 6053288839
• Email: Keith.Hansen[@]SanfordHealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Gender: Male
• Age group: 21 Years to 56 Years

Eligibility

Inclusion Criteria:

• Male with diagnosis of infertility.

Exclusion Criteria:

• Azoospermia

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Infertility,Male
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• Vitamin D
Blood will be drawn for Vitamin D level

Locations

Country	Name	City	State
United States	Sanford Health Fertility and Reproductive Medicine	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Blomberg Jensen M, Bjerrum PJ, Jessen TE, Nielsen JE, Joensen UN, Olesen IA, Petersen JH, Juul A, Dissing S, Jørgensen N. Vitamin D is positively associated with sperm motility and increases intracellular calcium in human spermatozoa. Hum Reprod. 2011 Jun;26(6):1307-17. doi: 10.1093/humrep/der059. Epub 2011 Mar 22. — View Citation

Blomberg Jensen M, Lawaetz JG, Petersen JH, Juul A, Jørgensen N. Effects of Vitamin D Supplementation on Semen Quality, Reproductive Hormones, and Live Birth Rate: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2018 Mar 1;103(3):870-881. doi: 10.1210/jc.2017-01656. — View Citation

Boisen IM, Bøllehuus Hansen L, Mortensen LJ, Lanske B, Juul A, Blomberg Jensen M. Possible influence of vitamin D on male reproduction. J Steroid Biochem Mol Biol. 2017 Oct;173:215-222. doi: 10.1016/j.jsbmb.2016.09.023. Epub 2016 Sep 28. Review. — View Citation

Bunde E, Hanssen K, Huntington MK. Vitamin D status in eastern South Dakota. S D Med. 2012 Jun;65(6):227, 229, 231. — View Citation

Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM. Guidelines for preventing and treating vitamin D deficiency and insufficiency revisited. J Clin Endocrinol Metab. 2012 Apr;97(4):1153-8. doi: 10.1210/jc.2011-2601. Epub 2012 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sperm motility	This will be determined by microscopic analysis of participant's semen and expressed as percent motile.	1 year
Other	Sperm morphology	This will be determined by microscopic analysis of participant's semen and will be expressed as percent normal forms.	1 year
Other	Height	Measured by stadiometer and recorded in centimeters.	1 year
Other	Weight	Measured using digital, medical scale	1 year
Other	BMI	weight and height will be combined to report BMI in kg/m^2	1 year
Other	Tobacco status	Patient will be asked if uses tobacco products: smoke, smokeless	1 year
Other	Race/ethnicity	Patient will self identify race/ethnicity	1 year
Primary	Sperm DNA Fragmentation	Human Sperm DNA fragmentation will be determined by the Sperm Chromatin Structure Assay.	1 year
Secondary	High DNA stainability	High DNA stainability is determined by the Sperm Chromatin Structure Assay and is consistent with immature sperm.	1 year
Secondary	Sperm density	This will be determined by microscopic analysis of participant's semen and expressed as millions per milliliter	1 year