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

Not Applicable

Completed

• Conditions: DNA Fingerprinting
• Interventions: Other: Polar body and embryo biopsy

• Registration Number: NCT01219517
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2009-05
• Study Completion: 2009-12
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Polar body and embryo biopsy	All patients in the study receive the same treatment. All will have 2 polar body biopsies and all embryos biopsied prior to transfer.

Primary Outcome Measures

Name	Time	Method
Validate DNA fingerprinting	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.

Trial Locations

Locations (6)

Colorado Center for Reproductive Medicine; 🇺🇸 Lone Tree, Colorado, United States

Reproductive Medicine Associates of Michigan; 🇺🇸 Troy, Michigan, United States

Reproductive Medicine Associates of New York; 🇺🇸 New York, New York, United States

Reproductive Medicine Associates of Connecticut; 🇺🇸 Norwalk, Connecticut, United States

Reproductive Medicine Associates of Vassar Brothers; 🇺🇸 Fishkill, New York, United States

Reproductive Medicine Associates; 🇺🇸 Morristown, New Jersey, United States