DNA FingerprintingNCT01219517
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
A study testing Polar body and embryo biopsy in people with DNA Fingerprinting, run by Reproductive Medicine Associates of New Jersey at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- DNA Fingerprinting
- What is being tested?
- Polar body and embryo biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Major Inclusion: The following are major inclusion criteria:
- Maximum of one prior failed IVF treatment cycle
- Female partner less than 43 years of age
- Normal day 3 FSH level (<12 mIU/mL)
- Basal antral follicle count greater than or equal to 8
- Ejaculated sperm specimen from the male partner with greater than 100,000 total motile
- Donor sperm okay if patient is willing to purchase 3 extra vials for DNA testing
Exclusions: The following are exclusion criteria:
- Diagnosis of chronic anovulation secondary to polycystic ovarian disease
- Diagnosis of endometrial insufficiency
- Clinical indication for PGD
- Testicular biopsy or aspiration procedures to obtain sperm
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Reproductive Medicine Associates of Vassar Brothers
Fishkill, New York, 12601
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
Reproductive Medicine Associates
Morristown, New Jersey, 07960
Reproductive Medicine Associates of New York
New York, New York, 10022
Reproductive Medicine Associates of Connecticut
Norwalk, Connecticut, 06850
Reproductive Medicine Associates of Michigan
Troy, Michigan, 48084
About this study
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.
Read the 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.
- Conditions
- DNA Fingerprinting
- Being tested
- Polar body and embryo biopsy
- Keywords
- IVF, embryo biopsy, DNA fingerprinting, SNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar body and embryo biopsyOther
Also called embryo biospy, SNP
2 polar bodies and all embryos will be biopsied prior to embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | All patients in the study receive the same treatment. All will have 2 polar body biopsies and all embryos biopsied prior to transfer. Receives: Other: Polar body and embryo biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate DNA fingerprinting
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.
Measured: After delivery of infant(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA FingerprintingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219517
- Sponsor's protocol ID
- RMA-00-18
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
- ClinicalTrials.gov ID
- NCT01219517
- Acronym / sponsor ID
- RMA-00-18
- Conditions
- DNA Fingerprinting
- Keywords
- IVF, embryo biopsy, DNA fingerprinting, SNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Polar body and embryo biopsyAll patients in the study receive the same treatment. All will have 2 polar body biopsies and all embryos biopsied prior to transfer. |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar body and embryo biopsyAlso: embryo biospy, SNP2 polar bodies and all embryos will be biopsied prior to embryo transfer. | Other | Study Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar body and embryo biopsy in people with DNA Fingerprinting, run by Reproductive Medicine Associates of New Jersey at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate DNA fingerprinting (time frame: After delivery of infant(s)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.