GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial

Study Overview
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Brief Summary
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The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.

Detailed Description
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In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants. Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center. In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known. In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer.

Official Title
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GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: Preimplantation genetic testing for aneuploidy (PGTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing IVF of between 35 and 40 years of age at IVF cycle start Utilization of Intracytoplasmic Sperm Injection ICSI (recommended) or Traditional IVF Utilization of ejaculated or testicular sperm Utilization of autologous or donor sperm All Controlled Ovarian Hyperstimulation (COH) protocols Exclusion Criteria: Utilization of donor oocytes Utilization of gestational carrier Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers Preimplantation genetic testing for monogenic/single gene disorders (PGT-M) Translocation carriers

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 40 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
Interventional Model Description: Prospective randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm - Transfer of Best Quality, Euploid Blastocyst<br>Transfer of best quality, PGTA normal (euploid) blastocyst. | Other: Preimplantation genetic testing for aneuploidy (PGTA)<br>* 24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)<br>|
| No Intervention: Control Arm - Transfer of Untested, Best Quality Blastocyst<br>Transfer of Untested, Best Quality Blastocyst | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy Rate | The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage Rate | Number of participants that experience a pregnancy loss after the 1st embryo transfer. | Up to 2 years |