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| Name | Class |
|---|---|
| Boston IVF | OTHER |
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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.
In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF center 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm - Transfer of Best Quality, Euploid Blastocyst | Experimental | Transfer of best quality, PGTA normal (euploid) blastocyst. |
|
| Control Arm - Transfer of Untested, Best Quality Blastocyst | No Intervention | Transfer of Untested, Best Quality Blastocyst |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preimplantation genetic testing for aneuploidy (PGTA) | Other | 24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy Rate | The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Miscarriage Rate | Number of participants that experience a pregnancy loss after the 1st embryo transfer. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Talia Metzgar | Contact | (973) 529- 4223 | talia@genomicprediction.com | |
| Kristin Rooney | Contact | (781) 434-6500 | krooney@bostonivf.com |
| Name | Affiliation | Role |
|---|---|---|
| Nathan Treff, PhD | Genomic Prediction Clinical Labortory | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston IVF | Recruiting | Waltham | Massachusetts | 02451 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29566854 | Background | 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. | |
| 22551456 |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Prospective randomized control trial
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Allocation information will be handled by embryology team at BIVF.
| Background |
| 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. |
| 23548942 | Background | 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. |
| 23731996 | Background | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |