Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)

NCT ID: NCT00875095

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to establish a new criteria with which to judge the quality of sperm samples submitted for artificial reproductive treatments. It is believed that this type of testing can compliment the traditional semen analysis to better drive patient care.

Detailed Description

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Conditions

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Sperm DNA Impact on ART Outcomes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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IUI patients

Patients undergoing routine semen analysis as part of their infertility treatment pertaining to success or failure with intrauterine insemination, based upon their sperm DNA integrity

No interventions assigned to this group

IVF patients

Couples undergoing routine screening prior to IVF retrievals to assess their reproductive treatment outcomes as compared to the sperm DNA integrity

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria

* severly oligozoospermic patients
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Organon

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Dennis Marchesi

laboratory supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avner Hershlag, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Dennis E Marchesi, MSc

Role: STUDY_DIRECTOR

Northwell Health

Locations

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The Center for Human Reproduction

Manhasset, New York, United States

Site Status

Countries

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United States

References

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Andreetta AM, Stockert JC, Barrera C. A simple method to detect sperm chromatin abnormalities: cytochemical mechanism and possible value in predicting semen quality in assisted reproductive procedures. Int J Androl. 1995 Jun;18 Suppl 1:23-8. doi: 10.1111/j.1365-2605.1995.tb00634.x.

Reference Type BACKGROUND
PMID: 7558384 (View on PubMed)

Chohan KR, Griffin JT, Lafromboise M, De Jonge CJ, Carrell DT. Comparison of chromatin assays for DNA fragmentation evaluation in human sperm. J Androl. 2006 Jan-Feb;27(1):53-9. doi: 10.2164/jandrol.05068.

Reference Type BACKGROUND
PMID: 16400078 (View on PubMed)

Erenpreiss J, Jepson K, Giwercman A, Tsarev I, Erenpreisa J, Spano M. Toluidine blue cytometry test for sperm DNA conformation: comparison with the flow cytometric sperm chromatin structure and TUNEL assays. Hum Reprod. 2004 Oct;19(10):2277-82. doi: 10.1093/humrep/deh417. Epub 2004 Jul 22.

Reference Type BACKGROUND
PMID: 15271869 (View on PubMed)

Erenpreisa J, Erenpreiss J, Freivalds T, Slaidina M, Krampe R, Butikova J, Ivanov A, Pjanova D. Toluidine blue test for sperm DNA integrity and elaboration of image cytometry algorithm. Cytometry A. 2003 Mar;52(1):19-27. doi: 10.1002/cyto.a.10015.

Reference Type BACKGROUND
PMID: 12596248 (View on PubMed)

Erenpreiss J, Bars J, Lipatnikova V, Erenpreisa J, Zalkalns J. Comparative study of cytochemical tests for sperm chromatin integrity. J Androl. 2001 Jan-Feb;22(1):45-53.

Reference Type BACKGROUND
PMID: 11191087 (View on PubMed)

Gavrieli Y, Sherman Y, Ben-Sasson SA. Identification of programmed cell death in situ via specific labeling of nuclear DNA fragmentation. J Cell Biol. 1992 Nov;119(3):493-501. doi: 10.1083/jcb.119.3.493.

Reference Type BACKGROUND
PMID: 1400587 (View on PubMed)

Said TM, Mahfouz R, Erenpreiss J, Giwercman A, Sharma RK, and Agarwal A. Association of intermediate staining patterns using the Toluidine blue test with late apoptosis and necrosis in human spermatozoa. 2006 Online ASRM abstract submission #06-A-1199-ASRM

Reference Type BACKGROUND

Said TM, Agarwal A, Erenpreiss J, Mahfouz R, Giwercman A, and Evenson DP. Evaluation of seminal fractions using Toluidine blue test and sperm chromatin structure assay. 2006 Online ASRM abstract submission #06-A-1123-ASRM

Reference Type BACKGROUND

Schlegel PN, Paduch DA. Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. doi: 10.1016/j.fertnstert.2005.04.050.

Reference Type BACKGROUND
PMID: 16213834 (View on PubMed)

World Health Organization (1999) WHO Laboratory manual for the examination of human semen ana sperm-cervical mucus interactions. 4rth ed. prepared by the WHO special programmed of research, development and research training in human reproduction. Cambridge University Press.

Reference Type BACKGROUND

Other Identifiers

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07.08.118

Identifier Type: -

Identifier Source: org_study_id

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