Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)
To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy. All viable blastocysts will be biopsied and cryopreserved for future transfer. After the final embryo is cryopreserved, patients will be randomized to either the intervention group or the control group. Patients and doctors are blinded to the randomization until study completion. A Double Embryo Transfer (DET) will be performed with either screened or unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in cases where only one embryo is available for transfer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)|
- Impact of next generation sequencing on the embryos produced from IVF on implantation rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the benefits, if any, of using next generation sequencing based Comprehensive Chromosome Screening (CCS) in the selection of embryos for transfer during clinical IVF cycles
- Delivery Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Comprehensive Chromosome Screening
Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples. Patients will proceed with a Double Embryo Transfer (DET) of the two morphologically best euploid embryos
Other: Comprehensive Chromosome Screening
On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.
Placebo Comparator: No Comprehensive Chromosome Screening
The patients in this group will proceed with a Double Embryo Transfer (DET) of the two morphologically best embryos.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02032264
|United States, New Jersey|
|Reproductive Medicine Associates of New Jersey|
|Basking Ridge, New Jersey, United States, 07920|
|Principal Investigator:||Richard T Scott, M.D., HCLD||Reproductive Medicine Associates of New Jersey|