Infertility Clinical Trial
— nexgenOfficial title:
Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
Verified date | March 2017 |
Source | Reproductive Medicine Associates of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 309 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey | Ferring Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of next generation sequencing on the embryos produced from IVF on implantation rates | 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 | 2 years | |
Secondary | Delivery Rates | 2 years |
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