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

This study has been completed.
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System Identifier:
First received: October 28, 2010
Last updated: March 14, 2014
Last verified: March 2014
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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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)


Genders 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
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: NCT01232465

United States, New York
Center for Human Reproduction
Manhasset, New York, United States, 11303
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Principal Investigator: Avner E Hershlag, MD Center for Human Reproduction
  More Information


Responsible Party: North Shore Long Island Jewish Health System Identifier: NCT01232465     History of Changes
Other Study ID Numbers: 10-249A
Study First Received: October 28, 2010
Results First Received: January 21, 2014
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
sperm DNA integrity
Toluidine blue assay (TBA)
IVF outcome

Additional relevant MeSH terms:
Abortion, Habitual
Infertility, Male
Abortion, Spontaneous
Genital Diseases, Female
Genital Diseases, Male
Pregnancy Complications processed this record on November 27, 2015