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(Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)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

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 July 20, 2014