Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Colorado
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Lone Tree、Colorado、美国、80124
- Colorado Center for Reproductive Medicine
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Connecticut
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Norwalk、Connecticut、美国、06850
- Reproductive Medicine Associates of Connecticut
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Michigan
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Troy、Michigan、美国、48084
- Reproductive Medicine Associates of Michigan
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New Jersey
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Morristown、New Jersey、美国、07960
- Reproductive Medicine Associates
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New York
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Fishkill、New York、美国、12601
- Reproductive Medicine Associates of Vassar Brothers
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New York、New York、美国、10022
- Reproductive Medicine Associates of New York
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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2 polar bodies and all embryos will be biopsied prior to embryo transfer.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Validate DNA fingerprinting
大体时间:After delivery of infant(s)
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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.
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After delivery of infant(s)
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合作者和调查者
调查人员
- 首席研究员:Richard T Scott, MD、Reproductive Medicine Associates of New Jersey
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RMA-00-18
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
DNA Fingerprinting的临床试验
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Bispebjerg HospitalSygehus Lillebaelt主动,不招人
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National Center for Tumor Diseases, HeidelbergAstraZeneca; German Cancer Research Center; PharmaMar主动,不招人
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University of ZagrebUniversity of Split, School of Medicine招聘中
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Tahitian Noni International, Inc.University of Illinois at Chicago完全的
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University of Colorado, BoulderNational Cancer Institute (NCI); National Institutes of Health (NIH)完全的