Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01219283
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2010-10-08
Brief Title:
Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis PGD
Sponsor:
Reproductive Medicine Associates of New Jersey
Organization:
Reproductive Medicine Associates of New Jersey
Study Overview
Official Title:
A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis PGD increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization IVF
Detailed Description:
FISH based PGD techniques have provided little improvement in implantation and delivery rates We believe that the use of 24 chromosome PGD as compared to control no PGD will show a benefit to patients This study is a randomized clinical trial that seeks to validate 24 chromosome PGD
Patients that meet the eligibility criteria will be randomized prior to embryo transfer In order to be randomized the patient must have blastulated embryos suitable for biopsy on day 5 Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infants
Patients that meet the eligibility criteria will be randomized prior to embryo transfer In order to be randomized the patient must have blastulated embryos suitable for biopsy on day 5 Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None