- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01219517
Validation of the Accuracy of DNA Fingerprinting Using Polar Bodies and Embryonic Cells
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Colorado
-
Lone Tree, Colorado, Forente stater, 80124
- Colorado Center for Reproductive Medicine
-
-
Connecticut
-
Norwalk, Connecticut, Forente stater, 06850
- Reproductive Medicine Associates of Connecticut
-
-
Michigan
-
Troy, Michigan, Forente stater, 48084
- Reproductive Medicine Associates of Michigan
-
-
New Jersey
-
Morristown, New Jersey, Forente stater, 07960
- Reproductive Medicine Associates
-
-
New York
-
Fishkill, New York, Forente stater, 12601
- Reproductive Medicine Associates of Vassar Brothers
-
New York, New York, Forente stater, 10022
- Reproductive Medicine Associates of New York
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Richard T Scott, MD, Reproductive Medicine Associates of New Jersey
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RMA-00-18
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på DNA Fingerprinting
-
Bispebjerg HospitalSygehus LillebaeltAktiv, ikke rekrutterendeDNA-skade | Ultrafiolette stråler; Skade | Dannelse av DNA-addukt | DNA-skade, strålingsindusertDanmark
-
National Center for Tumor Diseases, HeidelbergAstraZeneca; German Cancer Research Center; PharmaMarAktiv, ikke rekrutterendeKreft med DNA-reparasjonsmangelTyskland
-
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)FullførtDNA-metyleringForente stater
-
Chen Zi-JiangChinese Academy of SciencesFullført
-
Tahitian Noni International, Inc.University of Illinois at ChicagoFullførtDNA-skadeForente stater
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenUkjent
-
University Hospital, EssenHar ikke rekruttert ennåKreft | Stråling | DNATyskland
Kliniske studier på Polar body and embryo biopsy
-
University of South CarolinaAktiv, ikke rekrutterendeOverspising | Kroppsbilde | Spiseatferd | Ernæring, sunn | Uordnet spisingForente stater
-
Duke UniversityNational Institute of Mental Health (NIMH)Aktiv, ikke rekrutterendeARFID | Kresen spising | Spiseforstyrrelser hos barnForente stater
-
Jaeb Center for Health ResearchRekrutteringCystisk fibroseForente stater