Recruiting

Genetic Testing

Sponsor:

Genomic Prediction Inc.

Code:

NCT04167748

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 35 - 40

Healthy Volunteers: Not accepted

Interventions

Preimplantation genetic testing for aneuploidy (PGT-A)

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

NCT04167748

Start date

Mar 5, 2021

Status verified date

Aug, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov 1, 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
  • Utilization of ejaculated or testicular sperm
  • Utilization of autologous or donor sperm
  • All Controlled Ovarian Hyperstimulation (COH) protocols

Exclusion criteria:

  • Patients with anovulatory Polycystic ovarian syndrome (PCOS)
  • 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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PGT-A transfer

Transfer of single chromosomally normal (euploid) blastocyst after PGT-A

no intervention: Untested blastocyst transfer

Transfer of single untested blastocyst based on embryo morphology criteria.

Interventions

Preimplantation genetic testing for aneuploidy (PGT-A)

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

Primary outcome measure

  • Ongoing pregnancy rate [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Nathan R Treff, PhD

(973) 529-4223nathan@genomicprediction.com

Diego Marin, PhD

(973) 529-4223diego@genomicprediction.com

Locations

IVF Florida Reproductive Associates

Recruiting

Margate, Florida, United States, 33063

Contacts

Clinial Research

9542476200

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 2026-09-09. This information was provided to ClinicalTrials.gov by Genomic Prediction Inc. on 2025-08-26.