Infertility, FemaleGETSETNCT04167748
Preimplantation Genetic Testing in Women of Advanced Maternal Age
A study testing Preimplantation genetic testing for aneuploidy (PGT-A) in people with Infertility, Female, run by Genomic Prediction Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Preimplantation genetic testing for aneuploidy (PGT-A)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IVF Florida Reproductive Associates
Margate, Florida, 33063
Clinial Research, 9542476200
About this study
Official title: GEnetic Testing in Elective Single Embryo Transfer in Women of Advanced Maternal Age
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.
Read the detailed description
In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.
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 transfer with an untested blastocyst with the best morphology. 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. If the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected.
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, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.
- Conditions
- Infertility, Female
- Being tested
- Preimplantation genetic testing for aneuploidy (PGT-A)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation genetic testing for aneuploidy (PGT-A)Procedure or surgery
Also called Preimplantation genetic screening (PGS)
24-chromosome screening for aneuploidy in the preimplantation embryo (blastocyst stage)
| Study group | Role | What they receive |
|---|---|---|
| PGT-A transfer | Experimental | Transfer of single chromosomally normal (euploid) blastocyst after PGT-A Receives: Procedure: Preimplantation genetic testing for aneuploidy (PGT-A) |
| Untested blastocyst transfer | No intervention | Transfer of single untested blastocyst based on embryo morphology criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Number of patients who experience an ongoing pregnancy rate (>20 weeks of gestation) after their first embryo transfer
Measured: Up to 18 months
Secondary outcomes (1)
Miscarriage rate
Number of patients who experience a miscarriage after their first embryo transfer
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start5 Mar 2021
- Primary completion1 Nov 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genomic Prediction Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan R Treff, PhD, Principal investigator, Genomic Prediction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167748
- Sponsor's protocol ID
- Genomic Prediction Inc 624
- Acronym
- GETSET
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2019
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29566854Yang 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.
PubMed 22551456Forman 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.
PubMed 23548942Scott 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.
PubMed 23731996
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEnetic Testing in Elective Single Embryo Transfer in Women of Advanced Maternal Age
- ClinicalTrials.gov ID
- NCT04167748
- Acronym / sponsor ID
- GETSET / Genomic Prediction Inc 624
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Genomic Prediction Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.
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 transfer with an untested blastocyst with the best morphology. 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. If the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected.
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, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PGT-A transfer | Experimental | Procedure: Preimplantation genetic testing for aneuploidy (PGT-A)Transfer of single chromosomally normal (euploid) blastocyst after PGT-A |
| Untested blastocyst transfer | No intervention | –Transfer of single untested blastocyst based on embryo morphology criteria. |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preimplantation genetic testing for aneuploidy (PGT-A)Also: Preimplantation genetic screening (PGS)24-chromosome screening for aneuploidy in the preimplantation embryo (blastocyst stage) | Procedure or surgery | PGT-A transfer |
Primary outcome
Ongoing pregnancy rate
Time frame: Up to 18 months
Number of patients who experience an ongoing pregnancy rate (>20 weeks of gestation) after their first embryo transfer
1 secondary outcome
Miscarriage rate
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 29566854Practice 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.
- Background: PubMed 22551456Yang 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.
- Background: PubMed 23548942Forman 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.
- Background: PubMed 23731996Scott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan R Treff, PhD principal investigator
Genomic Prediction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preimplantation genetic testing for aneuploidy (PGT-A) in people with Infertility, Female, run by Genomic Prediction Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan R Treff, PhD ((973) 529-4223, nathan@genomicprediction.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167748, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.