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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01232465
First received: October 28, 2010
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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


Secondary Outcome Measures:
  • fertilization [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    observing whether sperm (tested for DNA integrity) successfully fertilizes retrieved eggs, via either IVF or intracytoplasmic sperm injection (ICSI)

  • embryo quality [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    assessing the quality of embryos created using a sperm sample that was tested for DNA integrity

  • blastocyst formation [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    observing the rate of blastocyst formation for embryos created with a sperm sample that was tested for DNA integrity

  • implantation rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    determining the successful implantation rate for embryos transferred after they were created using a sperm sample which was tested for DNA integrity.


Biospecimen Retention:   Samples Without DNA

slide smears will be kept to observe overall DNA integrity of sperm sample


Estimated Enrollment: 400
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
IVF
those individuals undergoing conventional IVF to inseminate their retrieved eggs
ICSI
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232465

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

Publications:

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01232465     History of Changes
Other Study ID Numbers: 10-249A
Study First Received: October 28, 2010
Last Updated: September 7, 2012
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
Infertility, Male
Abortion, Spontaneous
 Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013