Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141135
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-15
Brief Title:
GEnetic Testing in Elective Single Embryo Transfer GETSET A Randomized Clinical Trial
Sponsor:
Genomic Prediction Inc
Organization:
Genomic Prediction Inc
Study Overview
Official Title:
GEnetic Testing in Elective Single Embryo Transfer GETSET A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GETSET
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None