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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(Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875095
First Posted: April 3, 2009
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Organon
Information provided by (Responsible Party):
Dennis Marchesi, Northwell Health
  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:


Further study details as provided by Dennis Marchesi, 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)
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

Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

  • severly oligozoospermic patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875095


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

Publications:
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
ClinicalTrials.gov Identifier: NCT00875095     History of Changes
Other Study ID Numbers: 07.08.118
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by Dennis Marchesi, Northwell Health:
sperm DNA integrity
Toluidine blue staining