Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells

January 22, 2013 updated by: Reproductive Medicine Associates of New Jersey
The purpose of this study is to validate the ability to assess the genetic differences (DNA fingerprinting) on polar bodies (excess genetic material given off from the egg) and cells so that this technique may be used in the future to confirm markers of reproductive competence and improve the efficiency and safety of clinical human in vitro fertilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our group has recently validated a technique involving whole genomic amplification followed by single nucleotide polymorphisms (SNP) analysis which allows DNA fingerprinting of single cells. Given that there are more than 3.3 billion base pairs that constitute the human genome, there are approximately 3 million sites where routine variation in the genetic code exists. These SNPs have been identified on average to occur approximately once every 1000 base pairs (bp) and are present on all chromosomes.

100 couples will undergo routine in vitro fertilization (IVF) stimulation, the protocol to be determined by the patient's primary doctor. Following oocyte retrieval and intracytoplasmic sperm injection (ICSI), the first polar body will be biopsied using standard laboratory procedures, and sent for genetic analysis. 24 hours later, the second polar body will be biopsied and sent for genetic analysis. Finally, the embryos will be biopsied prior to transfer and the cell will be sent for gentic analysis. Genetic results are not available prior to transfer and there are be no delays in the treatment schedule as a result of the study. Buccal swabs are collected from infants. SNP profiles are created from the polar body and embryo biopsies which are then compared to the SNP profiles created from the buccal swabs.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Colorado Center for Reproductive Medicine
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Reproductive Medicine Associates of Connecticut
    • Michigan
      • Troy, Michigan, United States, 48084
        • Reproductive Medicine Associates of Michigan
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Associates
    • New York
      • Fishkill, New York, United States, 12601
        • Reproductive Medicine Associates of Vassar Brothers
      • New York, New York, United States, 10022
        • Reproductive Medicine Associates of New York

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

21 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Major Inclusion: The following are major inclusion criteria:

  1. Maximum of one prior failed IVF treatment cycle
  2. Female partner less than 43 years of age
  3. Normal day 3 FSH level (<12 mIU/mL)
  4. Basal antral follicle count greater than or equal to 8
  5. Ejaculated sperm specimen from the male partner with greater than 100,000 total motile
  6. Donor sperm okay if patient is willing to purchase 3 extra vials for DNA testing

Exclusions: The following are exclusion criteria:

  1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease
  2. Diagnosis of endometrial insufficiency
  3. Clinical indication for PGD
  4. Testicular biopsy or aspiration procedures to obtain sperm

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
All patients in the study receive the same treatment. All will have 2 polar body biopsies and all embryos biopsied prior to transfer.
Other: Polar body and embryo biopsy
2 polar bodies and all embryos will be biopsied prior to embryo transfer.
Other Names:
  • SNP
  • embryo biospy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate DNA fingerprinting
Time Frame: After delivery of infant(s)
Comparison of the SNP profile from the buccal swab as compared to the SNP profile of the 1st polar body biopsy, the SNP profile of the 2nd polar body biopsy and the SNP profile of the embryo biopsy will show which biopsy provides the greatest predictive value of the DNA of the conceptus.
After delivery of infant(s)

Collaborators and Investigators

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

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of new Jersey

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.

Helpful Links

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

January 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMA-00-18

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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