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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01232465
First received: October 28, 2010
Last updated: March 14, 2014
Last verified: March 2014
  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:


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)
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
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
Infertility, Male
Abortion, Spontaneous
Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014