Next Generation Sequencing Screening for Embryonic Ploidy Status
This trial is active, not recruiting.
|Treatments||comprehensive chromosome screening, morphologically best|
|Sponsor||Reproductive Medicine Associates of New Jersey|
|Start date||December 2013|
|End date||October 2016|
|Trial size||250 participants|
|Trial identifier||NCT02032264, RMA-2013-04|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
time frame: 2 years
time frame: 2 years
Female participants from 18 years up to 42 years old.
Inclusion Criteria: - Patient undergoing IVF/CCS (no PGD banking) - Patient meets ASRM guidelines for Double Embryo Transfer (DET) - Donor Sperm OK - AMH ≥ 1.2 - FSH ≤ 12 - BAFC ≥12 - 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
|Official title||Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)|
|Principal investigator||Richard T Scott, M.D., HCLD|
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