Trial record 2 of 191038 for:    ALL

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219517
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
DNA Fingerprinting
Other: Polar body and embryo biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Validate DNA fingerprinting [ Time Frame: After delivery of infant(s) ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • embryo biospy
  • SNP

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.

  Eligibility

Ages Eligible for Study:   21 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01219517

Locations
United States, Colorado
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Reproductive Medicine Associates of Connecticut
Norwalk, Connecticut, United States, 06850
United States, Michigan
Reproductive Medicine Associates of Michigan
Troy, Michigan, United States, 48084
United States, New Jersey
Reproductive Medicine Associates
Morristown, New Jersey, United States, 07960
United States, New York
Reproductive Medicine Associates of Vassar Brothers
Fishkill, New York, United States, 12601
Reproductive Medicine Associates of New York
New York, New York, United States, 10022
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219517     History of Changes
Other Study ID Numbers: RMA-00-18
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
IVF
embryo biopsy
DNA fingerprinting
SNP

ClinicalTrials.gov processed this record on May 25, 2015