Clinical trial NCT00875095: Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)
Official title: Impact of Sperm DNA Integrity on ART Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sperm DNA Impact on ART Outcomes
Keywords: sperm DNA integrity
Toluidine blue staining
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2009-04-03
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient population at the Center for Human Reproduction.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

* severly oligozoospermic patients

Primary outcomes:
measure: Sperm DNA integrity
timeFrame: 1 day
Secondary outcomes:
measure: achievement of a successful pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Center for Human Reproduction
state: New York
Study officials:
affiliation: Northwell Health
name: Avner Hershlag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Dennis E Marchesi, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: 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.