Preimplantation Genetic Testing for Women of Advanced Maternal Age

This study, called the GETSET trial, is looking at whether a procedure called Preimplantation Genetic Testing for Aneuploidy (PGT-A) can improve pregnancy rates for women aged 35 to 40 who are undergoing In Vitro Fertilization (IVF). PGT-A involves screening embryos for chromosome abnormalities before they are transferred. We want to see if transferring a single embryo that has been tested and found to be normal (euploid) leads to more ongoing pregnancies compared to transferring an untested embryo. The study plans to enroll 240 women who are undergoing IVF with Intracytoplasmic Sperm Injection (ICSI) using their own or donor sperm. The main goal is to measure the ongoing pregnancy rate up to 18 months after the embryo transfer.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to either receive PGT-A or not. A total of 240 women will participate, split evenly between two IVF centers.
What's involved
You would undergo standard IVF procedures including ovarian hyper-stimulation, egg retrieval, fertilization, and embryo culture. Depending on your assigned group, your embryos may undergo a biopsy for PGT-A.
Compensation
Not stated in the trial record.
Follow-up
Your pregnancy outcome will be followed for up to 18 months after the embryo transfer.

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NCT04167748

Preimplantation Genetic Testing in Women of Advanced Maternal Age

Recruiting
NAAges 35–40InterventionalTreatment
Genomic Prediction Inc.
~240 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:Preimplantation genetic testing for aneuploidy (PGT-A)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ongoing pregnancy rate
Measured over Up to 18 months
Infertility, Female
1 sites across 1 states
Florida1
  • Nathan R Treff, PhD · PRINCIPAL_INVESTIGATOR · Genomic Prediction

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Eligibility criteria

Inclusion

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

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
  • Ongoing pregnancy rateUp to 18 months

    Number of patients who experience an ongoing pregnancy rate (\>20 weeks of gestation) after their first embryo transfer