GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial
NCT ID: NCT06141135
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-11-15
2026-11-15
Brief Summary
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Detailed Description
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Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.
In the control arm, patients will undergo a single frozen embryo transferof the untested, best quality blastocyst. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known.
In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Arm - Transfer of Best Quality, Euploid Blastocyst
Transfer of best quality, PGTA normal (euploid) blastocyst.
Preimplantation genetic testing for aneuploidy (PGTA)
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)
Control Arm - Transfer of Untested, Best Quality Blastocyst
Transfer of Untested, Best Quality Blastocyst
No interventions assigned to this group
Interventions
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Preimplantation genetic testing for aneuploidy (PGTA)
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)
Eligibility Criteria
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Inclusion Criteria
* 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 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
35 Years
40 Years
FEMALE
No
Sponsors
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Boston IVF
OTHER
Genomic Prediction Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nathan Treff, PhD
Role: PRINCIPAL_INVESTIGATOR
Genomic Prediction Clinical Labortory
Locations
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Boston IVF
Waltham, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Electronic address: [email protected]; Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. The use of preimplantation genetic testing for aneuploidy (PGT-A): a committee opinion. Fertil Steril. 2018 Mar;109(3):429-436. doi: 10.1016/j.fertnstert.2018.01.002.
Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.
Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
Other Identifiers
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GPCL 20232892
Identifier Type: -
Identifier Source: org_study_id
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