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Genetic Testing

Genetic Testing for Infertility (GETSET Trial)

N/A
Recruiting
Led By Nathan Treff, PhD
Research Sponsored by Genomic Prediction Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Utilization of autologous or donor sperm
All Controlled Ovarian Hyperstimulation (COH) protocols
Must not have
Preimplantation genetic testing for monogenic/single gene disorders (PGT-M)
Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the benefits of a genetic test before embryo transfer to improve pregnancy outcomes in women aged 35-40.

Who is the study for?
The GETSET trial is for women aged 35-40 undergoing IVF with their own or donor sperm, and any COH protocol. It's not for those using donor eggs, gestational carriers, have had ≥3 miscarriages in a row, ≥3 failed embryo transfers, need genetic testing for single gene disorders or are translocation carriers.
What is being tested?
This study tests if preimplantation genetic testing for aneuploidies (PGT-A) improves pregnancy outcomes when used during elective single embryo transfer in IVF treatments for women between the ages of 35 and 40.
What are the potential side effects?
Since PGT-A involves testing embryos before implantation without using drugs or medical procedures on participants directly, it generally does not have side effects like medications do. However, usual IVF-related risks still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using my own or donor sperm for treatment.
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I am undergoing or have undergone ovarian stimulation treatment.
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I am using or plan to use ICSI or traditional IVF for conception.
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I am using ejaculated or testicular sperm for conception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone genetic testing for specific inherited disorders.
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I have had 3 or more unsuccessful embryo transfers.
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I have a genetic change known as a translocation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ongoing Pregnancy Rate
Secondary study objectives
Miscarriage Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm - Transfer of Best Quality, Euploid BlastocystExperimental Treatment1 Intervention
Transfer of best quality, PGTA normal (euploid) blastocyst.
Group II: Control Arm - Transfer of Untested, Best Quality BlastocystActive Control1 Intervention
Transfer of Untested, Best Quality Blastocyst

Find a Location

Who is running the clinical trial?

Genomic Prediction Inc.Lead Sponsor
5 Previous Clinical Trials
11,440 Total Patients Enrolled
Boston IVFOTHER
19 Previous Clinical Trials
19,984 Total Patients Enrolled
Nathan Treff, PhDPrincipal InvestigatorGenomic Prediction Clinical Labortory
~120 spots leftby Nov 2025
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