NCT00875095|Terminated
Study Stopped
Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.
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Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.
Sponsor study identifier
observational
8
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 2008
Actual (reported)December 2008
Actual (reported)April 2, 2009
Actual (reported)April 3, 2009
Actual (reported)Sperm DNA integrity
1 day
achievement of a successful pregnancy
1 year
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
Couples undergoing routine screening prior to IVF retrievals to assess their reproductive treatment outcomes as compared to the sperm DNA integrity
patient population at the Center for Human Reproduction.
The Center for Human Reproduction
Manhasset, New York, 11030, United States
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.
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.
Smears of semen samples will be stained and stored.
Avner Hershlag, MD
Northwell Health
Dennis E Marchesi, MSc
Northwell Health
8 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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
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
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.
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.
Primary Completion
December 2008
Actual (reported)Study Completion
December 2008
Actual (reported)Last Updated
September 8, 2016
Record last verified: 2016-09
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