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(Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)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

Tracking Information

First Received Date ^ICMJE

April 2, 2009

Last Updated Date

November 6, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00875095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Impact of Sperm DNA Integrity on ART Treatment

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Smears of semen samples will be stained and stored.

Sampling Method

Non-Probability Sample

Study Population

patient population at the Center for Human Reproduction.

Condition ^ICMJE

Sperm DNA Impact on ART Outcomes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

severly oligozoospermic patients

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00875095

Other Study ID Numbers ^ICMJE

07.08.118

Has Data Monitoring Committee

Responsible Party

Avner Hershlag, MD, North Shore-Long Island Jewish Health System

Study Sponsor ^ICMJE

North Shore Long Island Jewish Health System

Collaborators ^ICMJE

Organon

Investigators ^ICMJE

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

Information Provided By

North Shore Long Island Jewish Health System

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top