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

This study has been terminated.

(Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)

Sponsor:

Collaborator:

Organon

Information provided by:

North Shore Long Island Jewish Health System

ClinicalTrials.gov Identifier:

NCT00875095

First received: April 2, 2009

Last updated: November 6, 2009

Last verified: November 2009

History of Changes

Purpose

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.

Condition
Sperm DNA Impact on ART Outcomes

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Impact of Sperm DNA Integrity on ART Treatment

Resource links provided by NLM:

Drug Information available for: Deoxyribonucleic acid

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Sperm DNA integrity [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

achievement of a successful pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Smears of semen samples will be stained and stored.

Estimated Enrollment:	1000
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

patient population at the Center for Human Reproduction.

Criteria

Inclusion Criteria:

needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

severly oligozoospermic patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875095

Locations

United States, New York
The Center for Human Reproduction
Manhasset, New York, United States, 11030

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Organon

Investigators

Principal Investigator:	Avner Hershlag, MD	North Shore Long Island Jewish Health System
Study Chair:	Huai L Feng, PhD	North Shore Long Island Jewish Health System
Study Director:	Dennis E Marchesi, MSc	North Shore Long Island Jewish Health System

More Information

Publications:

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.

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.

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. 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.

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.

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. Review.

Responsible Party:	Avner Hershlag, MD, North Shore-Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00875095 History of Changes
Other Study ID Numbers:	07.08.118
Study First Received:	April 2, 2009
Last Updated:	November 6, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

sperm DNA integrity
Toluidine blue staining

ClinicalTrials.gov processed this record on May 19, 2013

To Top