Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01219283|
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : March 26, 2015
|Condition or disease|
|Effect of PGD on Implantation Rates in IVF Cycles|
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 infant(s).
|Study Type :||Observational|
|Actual Enrollment :||334 participants|
|Observational Model:||Case Control|
|Official Title:||A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Control (no PGD)
Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred.
Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred.
- Sustained Implantation Rate Per Embryo Transferred [ Time Frame: Within 1 year ]Implantation rate per embryo transferred
- Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle [ Time Frame: Within 1 Year ]Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219283
|United States, Colorado|
|Colorado Center for Reproductive Medicine|
|Lone Tree, Colorado, United States, 18104|
|United States, New Jersey|
|Reproductive Medicine Associates|
|Morristown, New Jersey, United States, 07960|
|United States, Pennsylvania|
|Reproductive Medicine Associates of PA at Lehigh Valley|
|Allentown, Pennsylvania, United States, 18104|
|Principal Investigator:||Richard T Scott, MD||Reproductive Medicine Associates of New Jersey|