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

Genomic Prediction

Status: Enrolling

Conditions: Infertility, Female

Treatments: Other: Preimplantation genetic testing for aneuploidy (PGTA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06141135

GPCL 20232892

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 35 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

Experimental Arm - Transfer of Best Quality, Euploid Blastocyst

Experimental group

Description:

Transfer of best quality, PGTA normal (euploid) blastocyst.

Treatment:

Other: Preimplantation genetic testing for aneuploidy (PGTA)

Control Arm - Transfer of Untested, Best Quality Blastocyst

No Intervention group

Description:

Transfer of Untested, Best Quality Blastocyst