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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 belowSelect...
I am using my own or donor sperm for treatment.
Select...
I am undergoing or have undergone ovarian stimulation treatment.
Select...
I am using or plan to use ICSI or traditional IVF for conception.
Select...
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:Select...
I have undergone genetic testing for specific inherited disorders.
Select...
I have had 3 or more unsuccessful embryo transfers.
Select...
I have a genetic change known as a translocation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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