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

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.
 
ClinicalTrials.gov Identifier: NCT00875095
Recruitment Status : Terminated (Study funding was withdrawn by the sponsor following agreement that slow patient recruitment warranted a new approach.)
First Posted : April 3, 2009
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Dennis Marchesi, Northwell Health

Tracking Information
First Submitted Date April 2, 2009
First Posted Date April 3, 2009
Last Update Posted Date September 8, 2016
Study Start Date October 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2009)
Sperm DNA integrity [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00875095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 2, 2009)
achievement of a successful pregnancy [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)
Official Title 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 Observational
Study Design 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 Sperm DNA Impact on ART Outcomes
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 17, 2015)
8
Original Estimated Enrollment
 (submitted: April 2, 2009)
1000
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • needs interventions through artificial reproductive treatment to achieve a pregnancy

Exclusion Criteria:

  • severly oligozoospermic patients
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00875095
Other Study ID Numbers 07.08.118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dennis Marchesi, Northwell Health
Study Sponsor Northwell Health
Collaborators Organon
Investigators
Principal Investigator: Avner Hershlag, MD Northwell Health
Study Director: Dennis E Marchesi, MSc Northwell Health
PRS Account Northwell Health
Verification Date September 2016