NCT03829943

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.

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
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

January 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 21, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

January 31, 2019

Last Update Submit

October 8, 2020

Conditions

Infertility,MaleVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Sperm DNA Fragmentation

    Human Sperm DNA fragmentation will be determined by the Sperm Chromatin Structure Assay.

    1 year

Secondary Outcomes (2)

  • High DNA stainability

    1 year

  • Sperm density

    1 year

Other Outcomes (7)

  • Sperm motility

    1 year

  • Sperm morphology

    1 year

  • Height

    1 year

  • +4 more other outcomes

Study Arms (2)

Vitamin D deficiency

The study group will be males discovered to have Vitamin D deficiency.

Diagnostic Test: Vitamin D

Control group

The control group will be males with normal Vitamin D status

Diagnostic Test: Vitamin D

Interventions

Vitamin DDIAGNOSTIC_TEST

Blood will be drawn for Vitamin D level

Control groupVitamin D deficiency

Eligibility Criteria

Age21 Years - 56 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male partners of infertile couples. All males who present to our Infertility clinic will be offered participation.

You may qualify if:

  • Male with diagnosis of infertility.

You may not qualify if:

  • Azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health Fertility and Reproductive Medicine

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Related Publications (5)

  • Blomberg Jensen M, Bjerrum PJ, Jessen TE, Nielsen JE, Joensen UN, Olesen IA, Petersen JH, Juul A, Dissing S, Jorgensen 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.

    PMID: 21427118BACKGROUND

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

    PMID: 22856011BACKGROUND

  • Boisen IM, Bollehuus 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.

    PMID: 27693423BACKGROUND

  • Blomberg Jensen M, Lawaetz JG, Petersen JH, Juul A, Jorgensen 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.

    PMID: 29126319BACKGROUND

  • 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. No abstract available.

    PMID: 22442274BACKGROUND

MeSH Terms

Conditions

Infertility, MaleVitamin D Deficiency

Interventions

Vitamin D Response Element

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Response ElementsEnhancer Elements, GeneticRegulatory Sequences, Nucleic AcidBase SequenceMolecular StructureBiochemical PhenomenaChemical PhenomenaPromoter Regions, GeneticGenetic StructuresGenetic PhenomenaRegulatory Elements, TranscriptionalGene ComponentsGenesGenome ComponentsGenome

Central Study Contacts

Keith A Hansen, MD

CONTACT

6053288839Keith.Hansen@SanfordHealth.org

Angela Haldeman, RN

CONTACT

6053288800Angela.Haldeman@SanfordHealth.org

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

January 31, 2019

First Posted

February 4, 2019

Study Start

March 21, 2019

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

October 12, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Plan to share individual participant data (IPD) with researchers who desire information.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available after collection complete and will remain available for 3 years.
Access Criteria
Investigator.

Locations

US(1)