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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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DNA Fingerprinting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Polar body and embryo biopsy

Intervention Type OTHER

2 polar bodies and all embryos will be biopsied prior to embryo transfer.

Interventions

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Polar body and embryo biopsy

2 polar bodies and all embryos will be biopsied prior to embryo transfer.

Intervention Type OTHER

Other Intervention Names

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embryo biospy SNP

Eligibility Criteria

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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

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes