- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01219517
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Colorado
-
Lone Tree, Colorado, Forenede Stater, 80124
- Colorado Center for Reproductive Medicine
-
-
Connecticut
-
Norwalk, Connecticut, Forenede Stater, 06850
- Reproductive Medicine Associates of Connecticut
-
-
Michigan
-
Troy, Michigan, Forenede Stater, 48084
- Reproductive Medicine Associates of Michigan
-
-
New Jersey
-
Morristown, New Jersey, Forenede Stater, 07960
- Reproductive Medicine Associates
-
-
New York
-
Fishkill, New York, Forenede Stater, 12601
- Reproductive Medicine Associates of Vassar Brothers
-
New York, New York, Forenede Stater, 10022
- Reproductive Medicine Associates of New York
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
2 polar bodies and all embryos will be biopsied prior to embryo transfer.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Validate DNA fingerprinting
Tidsramme: 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.
|
After delivery of infant(s)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Richard T Scott, MD, Reproductive Medicine Associates of New Jersey
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RMA-00-18
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med DNA Fingerprinting
-
Bispebjerg HospitalSygehus LillebaeltAktiv, ikke rekrutterendeDNA-skade | Ultraviolette stråler; Skade | Dannelse af DNA-addukt | DNA-skade, strålingsinduceretDanmark
-
University of ZagrebUniversity of Split, School of MedicineRekruttering
-
University of Split, School of MedicineRekruttering
-
University of Colorado, BoulderNational Cancer Institute (NCI); National Institutes of Health (NIH)AfsluttetDNA-methyleringForenede Stater
-
Cancer Council VictoriaAfsluttetDNA-methylering
-
National Center for Tumor Diseases, HeidelbergAstraZeneca; German Cancer Research Center; PharmaMarAktiv, ikke rekrutterendeKræft med DNA-reparation-mangelTyskland
-
Chen Zi-JiangChinese Academy of SciencesAfsluttet
-
Tahitian Noni International, Inc.University of Illinois at ChicagoAfsluttetDNA-skadeForenede Stater
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenUkendtDNA-methyleringBelgien
-
University Hospital, EssenIkke rekrutterer endnuKræft | Stråling | DNATyskland
Kliniske forsøg med Polar body and embryo biopsy
-
Weill Medical College of Cornell UniversityAfsluttet
-
Duke UniversityNational Institute of Mental Health (NIMH)Aktiv, ikke rekrutterendeARFID | Kræsen spisning | Spiseforstyrrelser hos børnForenede Stater
-
Jaeb Center for Health ResearchRekrutteringCystisk fibroseForenede Stater