Infertility
Conditions
Keywords
Next generation sequencing, Embryonic aneuploidy
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.
Interventions
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.
OTHERMorphologically 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
Sponsors
Ferring Pharmaceuticals
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of next generation sequencing on the embryos produced from IVF on implantation rates | 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
| Measure | Time frame |
|---|---|
| Delivery Rates | 2 years |
Countries
United States
Outcome results
None listed