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

Last updated: August 19, 2025
Sponsor: Genomic Prediction Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Preimplantation genetic testing for aneuploidy (PGTA)

Clinical Study ID

NCT06141135
GPCL 20232892
  • Ages 35-40
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 ---TraditionalIVF

  • Utilization of ejaculated or testicular sperm

  • Utilization of autologous or donor sperm

  • All Controlled Ovarian Hyperstimulation (COH) protocols

Exclusion

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

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Preimplantation genetic testing for aneuploidy (PGTA)
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
November 15, 2026

Study 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.

Connect with a study center

  • Boston IVF

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Boston IVF

    Waltham 4954380, Massachusetts 6254926 02451
    United States

    Active - Recruiting

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