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Impact of Sperm DNA Integrity on In Vitro Cycles (TBA on IVF)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 2, 2010
Last Update Posted: April 11, 2014
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.
Information provided by (Responsible Party):
Northwell Health
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.

Male Infertility Unexplained Infertility Abortion, Habitual

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Impact of Sperm DNA Integrity on In Vitro Cycles

Resource links provided by NLM:

Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 9 months ]
    detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth

Biospecimen Retention:   Samples Without DNA
slide smears will be kept to observe overall DNA integrity of sperm sample

Enrollment: 420
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
those individuals undergoing conventional IVF to inseminate their retrieved eggs
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY

Inclusion Criteria:

  • couple undergoing IVF at the Center for Human Reproduction
  • sperm sample given from partner (not a donor)

Exclusion Criteria:

  • low sperm concentration (<5 million/cc)
  • using a donor sample
  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): NCT01232465

United States, New York
Center for Human Reproduction
Manhasset, New York, United States, 11303
Sponsors and Collaborators
Northwell Health
Principal Investigator: Avner E Hershlag, MD Center for Human Reproduction
  More Information


Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01232465     History of Changes
Other Study ID Numbers: 10-249A
First Submitted: October 28, 2010
First Posted: November 2, 2010
Results First Submitted: January 21, 2014
Results First Posted: March 6, 2014
Last Update Posted: April 11, 2014
Last Verified: March 2014

Keywords provided by Northwell Health:
sperm DNA integrity
Toluidine blue assay (TBA)
IVF outcome

Additional relevant MeSH terms:
Infertility, Male
Abortion, Habitual
Genital Diseases, Male
Genital Diseases, Female
Abortion, Spontaneous
Pregnancy Complications