Recruiting

Genetic Testing

Sponsor:

Genomic Prediction Inc.

Code:

NCT06141135

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 35 - 40

Healthy Volunteers: Not accepted

Interventions

Preimplantation genetic testing for aneuploidy (PGTA)

Study Details

Brief 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.

Conditions

Infertility, Female

Study ID

NCT06141135

Start date

Nov 15, 2023

Status verified date

Aug, 2025

Completion date

Nov 15, 2026

Anticipated

Primary completion date

Nov 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm - Transfer of Best Quality, Euploid Blastocyst

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

no intervention: Control Arm - Transfer of Untested, Best Quality Blastocyst

Transfer of Untested, Best Quality Blastocyst

Interventions

Preimplantation genetic testing for aneuploidy (PGTA)

24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)

Primary outcome measure

  • Ongoing Pregnancy Rate [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Talia Metzgar

(973) 529- 4223talia@genomicprediction.com

Kristin Rooney

(781) 434-6500krooney@bostonivf.com

Locations

Boston IVF

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

Kristin Rooney

(781) 434-6500krooney@bivf.com

Principal Investigator:

Kim Thorton, MD

More Information

Sponsor

Genomic Prediction Inc.

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genomic Prediction Inc. on 2025-08-26.