NCT02032264

Next Generation Sequencing Screening for Embryonic Ploidy Status

Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infertility

Interventions

Type	Name	Description
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.
OTHER	Morphologically Best	Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2014-01-10
• Last updated: 2017-03-17

Locations

1 site across 1 country: United States