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

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ClinicalTrials.gov Identifier: NCT01219517
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

October 8, 2010
October 13, 2010
January 23, 2013
January 2008
May 2009   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01219517 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
DNA Fingerprinting
Other: Polar body and embryo biopsy
2 polar bodies and all embryos will be biopsied prior to embryo transfer.
Other Names:
  • embryo biospy
  • SNP
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.
Intervention: Other: Polar body and embryo biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
December 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 43 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01219517
RMA-00-18
No
Not Provided
Not Provided
Reproductive Medicine Associates of New Jersey
Reproductive Medicine Associates of New Jersey
Not Provided
Principal Investigator: Richard T Scott, MD Reproductive Medicine Associates of New Jersey
Reproductive Medicine Associates of New Jersey
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP