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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(Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)
Information provided by (Responsible Party):
Dennis Marchesi, Northwell Health Identifier:
First received: April 2, 2009
Last updated: September 7, 2016
Last verified: September 2016
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.

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:

Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Sperm DNA integrity [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • achievement of a successful pregnancy [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Smears of semen samples will be stained and stored.

Enrollment: 8
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patient population at the Center for Human Reproduction.

Inclusion Criteria:

  • needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

  • severly oligozoospermic patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00875095

United States, New York
The Center for Human Reproduction
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Principal Investigator: Avner Hershlag, MD Northwell Health
Study Director: Dennis E Marchesi, MSc Northwell Health
  More Information

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
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.

Responsible Party: Dennis Marchesi, laboratory supervisor, Northwell Health Identifier: NCT00875095     History of Changes
Other Study ID Numbers: 07.08.118
Study First Received: April 2, 2009
Last Updated: September 7, 2016

Keywords provided by Northwell Health:
sperm DNA integrity
Toluidine blue staining processed this record on April 24, 2017