Infertility, Female
Conditions
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.
Interventions
OTHERPreimplantation genetic testing for aneuploidy (PGTA)
24 chromosome screening for aneuploidy in the preimplantation embryo(blastocyst stage)
Sponsors
Boston IVF
Genomic Prediction Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Allocation information will be handled by embryology team at BIVF.
Intervention model description
Prospective randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing Pregnancy Rate | Up to 2 years | The number of participants who experience an ongoing clinical pregnancy rate after the 1st embryo transfer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage Rate | Up to 2 years | Number of participants that experience a pregnancy loss after the 1st embryo transfer. |
Countries
United States
Contacts
Primary ContactTalia Metzgar
Backup ContactKristin Rooney
Outcome results
None listed