Next Generation Sequencing Screening for Embryonic Ploidy Status

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Comprehensive Chromosome Screening
* Other: Morphologically Best


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Chromosome Screening<br>Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples. Patients will proceed with a single or double embryo transfer of the one or two morphologically best euploid embryos | Other: Comprehensive Chromosome Screening<br>* 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.<br>* Other names: CCS;|
| Placebo Comparator: No Comprehensive Chromosome Screening<br>The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos. | Other: Morphologically Best<br>* 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<br>* Other names: No CCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Rates |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Next generation sequencing, Embryonic aneuploidy