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Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.
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| Name | Class |
|---|---|
| Organon | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| IVF patients | Couples undergoing routine screening prior to IVF retrievals to assess their reproductive treatment outcomes as compared to the sperm DNA integrity |
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| Measure | Description | Time Frame |
|---|---|---|
| Sperm DNA integrity | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| achievement of a successful pregnancy | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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patient population at the Center for Human Reproduction.
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| Name | Affiliation | Role |
|---|---|---|
| Avner Hershlag, MD | Northwell Health | Principal Investigator |
| Dennis E Marchesi, MSc | Northwell Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Human Reproduction | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7558384 | Background | 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. | |
| 16400078 | Background | 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. |
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Smears of semen samples will be stained and stored.
| 15271869 | Background | 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. |
| 12596248 | Background | 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. |
| 11191087 | Background | 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. |
| 1400587 | Background | 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. |
| Background | 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 |
| 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 |
| 16213834 | 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. |
| Background | 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. |