Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Reproductive Medicine Associates of New Jersey
- Enrollment
- 309
- Locations
- 1
- Primary Endpoint
- Impact of next generation sequencing on the embryos produced from IVF on implantation rates
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient undergoing IVF/CCS (no PGD banking)
- •Patient meets ASRM guidelines for Double Embryo Transfer (DET)
- •Donor Sperm OK
- •AMH ≥ 1.2
- •Max 1 prior failed IVF cycle for patients 35-45 years old
- •Patient \<35 years old MUST have 1 prior failed IVF cycle
Exclusion Criteria
- •Chronic endometrial insufficiency
- •Use of oocyte donor or gestational carriers
- •Medical contraindications to Double Embryo Transfer (DET)
- •Male Factor (\<100,000 sperm or surgical sperm)
- •Communicating hydrosalpinx (on HSG)
- •Single gene disorders or sex selection
Outcomes
Primary Outcomes
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
Time Frame: 2 years
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
Secondary Outcomes
- Delivery Rates(2 years)