GEnetic Testing in Elective Single Embryo Transfer (GETSET): A Randomized Clinical Trial
GETSET
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
ExpectedAugust 26, 2025
August 1, 2025
2 years
November 15, 2023
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy Rate
The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer.
Up to 2 years
Secondary Outcomes (1)
Miscarriage Rate
Up to 2 years
Study Arms (2)
Experimental Arm - Transfer of Best Quality, Euploid Blastocyst
EXPERIMENTALTransfer of best quality, PGTA normal (euploid) blastocyst.
Control Arm - Transfer of Untested, Best Quality Blastocyst
NO INTERVENTIONTransfer of Untested, Best Quality Blastocyst
Interventions
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)
Eligibility Criteria
You may qualify if:
- Women undergoing IVF of between 35 and 40 years of age at IVF cycle start
- 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
You may not qualify if:
- 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
- Preimplantation genetic testing for monogenic/single gene disorders (PGT-M)
- Translocation carriers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genomic Prediction Inc.lead
- Boston IVFcollaborator
Study Sites (1)
Boston IVF
Waltham, Massachusetts, 02451, United States
Related Publications (4)
Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Electronic address: ASRM@asrm.org; 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.
PMID: 29566854BACKGROUNDYang 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.
PMID: 22551456BACKGROUNDForman 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.
PMID: 23548942BACKGROUNDScott 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.
PMID: 23731996BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Treff, PhD
Genomic Prediction Clinical Labortory
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Allocation information will be handled by embryology team at BIVF.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 21, 2023
Study Start
November 15, 2023
Primary Completion
November 15, 2025
Study Completion (Estimated)
November 15, 2026
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share