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

March 14, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11303
        • Center for Human Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
IVF
those individuals undergoing conventional IVF to inseminate their retrieved eggs
ICSI
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Avner E Hershlag, MD, Center for Human Reproduction

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-249A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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