GEnetic Testing in Elective Single Embryo Transfer in Women of Advanced Maternal Age
Genomic Prediction Inc.
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.
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…
Eligibility
- Age range
- 35–40 years
- Sex
- Female
- 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 * Utilization of ejaculated or testicular sperm * Utilization of autologous or donor sperm * All Controlled Ovarian Hyperstimulation (COH) protocols Exclusion criteria: * 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…
Interventions
- ProcedurePreimplantation genetic testing for aneuploidy (PGT-A)
24-chromosome screening for aneuploidy in the preimplantation embryo (blastocyst stage)
Location
- IVF Florida Reproductive AssociatesMargate, Florida