Trial Summary
What is the purpose of this trial?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.
What safety data exists for genetic testing for infertility (PGT-A)?Existing safety data indicates that preimplantation genetic testing for aneuploidy (PGT-A) is not associated with adverse obstetric and neonatal outcomes in singleton pregnancies. However, the clinical benefits, particularly in specific populations like young patients with recurrent pregnancy failure, remain uncertain. Overall, PGT-A is considered safe in terms of obstetric and neonatal outcomes, but its effectiveness and the populations that benefit most are still being studied.36789
Is Preimplantation genetic testing for aneuploidy (PGT-A) a promising treatment for infertility?Preimplantation genetic testing for aneuploidy (PGT-A) is a promising treatment because it helps select embryos with the right number of chromosomes, which can improve the chances of a successful pregnancy and reduce the risk of miscarriage. It is increasingly used in IVF to improve live birth rates by ensuring healthier embryos are chosen for transfer.25689
What data supports the idea that Genetic Testing for Infertility is an effective treatment?The available research shows that Genetic Testing for Infertility, also known as PGT-A, can improve the chances of successful pregnancy outcomes. Specifically, it has been shown to increase implantation and pregnancy rates while reducing miscarriage rates compared to traditional methods of selecting embryos based on appearance. However, its effectiveness may be limited for patients with fewer embryos to choose from. Additionally, while PGT-A improves per-cycle live-birth rates, the overall success rate across multiple cycles is similar to traditional methods. This suggests that while PGT-A can be beneficial, its advantages may vary depending on individual circumstances.13478
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
The GETSET trial is for women aged 35-40 undergoing IVF with their own or donor sperm, and any COH protocol. It's not for those using donor eggs, gestational carriers, have had ≥3 miscarriages in a row, ≥3 failed embryo transfers, need genetic testing for single gene disorders or are translocation carriers.Inclusion Criteria
I am using my own or donor sperm for treatment.
I am undergoing or have undergone ovarian stimulation treatment.
I am using or plan to use ICSI or traditional IVF for conception.
I am using ejaculated or testicular sperm for conception.
Exclusion Criteria
I have undergone genetic testing for specific inherited disorders.
I have had 3 or more unsuccessful embryo transfers.
I have a genetic change known as a translocation.
Treatment Details
This study tests if preimplantation genetic testing for aneuploidies (PGT-A) improves pregnancy outcomes when used during elective single embryo transfer in IVF treatments for women between the ages of 35 and 40.
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm - Transfer of Best Quality, Euploid BlastocystExperimental Treatment1 Intervention
Transfer of best quality, PGTA normal (euploid) blastocyst.
Group II: Control Arm - Transfer of Untested, Best Quality BlastocystActive Control1 Intervention
Transfer of Untested, Best Quality Blastocyst
Preimplantation genetic testing for aneuploidy (PGT-A) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as PGT-A for:
- Screening for aneuploidy in embryos generated through IVF
🇪🇺 Approved in European Union as PGT-A for:
- Screening for aneuploidy in embryos generated through IVF
Find a clinic near you
Research locations nearbySelect from list below to view details:
Boston IVFWaltham, MA
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Who is running the clinical trial?
Genomic Prediction Inc.Lead Sponsor
Boston IVFCollaborator
References
The dilemma of aneuploidy screening on low responders. [2019]Preimplantation genetic testing for aneuploidy (PGT-A) has been demonstrated to improve implantation and pregnancy rates and decrease miscarriage rates over standard morphology-based embryo selection. However, there are limited data on its efficacy in patients with diminished ovarian reserve or a poor response to stimulation who may have fewer embryos to select amongst.
Aneuploidy Screening using Next Generation Sequencing. [2019]Chromosomal aneuploidy is recognized to be a significant contributing factor in implantation failure and spontaneous miscarriage Hellani et al. (Reprod Biomed Online 17:841-847, 2008), Vanneste et al. (Nat Med 15:577-583, 2009) and is likely to be responsible for the majority of IVF failure [Baltaci et al. (Reprod Biomed Online 12:77-82, 2006), Munne (Placenta 24:S70-76, 2003)]. Preimplantation genetic testing for aneuploidy (PGT-A) screening, formerly termed preimplantation genetic screening (PGS), enables the assessment of the numeric chromosomal constitution in blastomere and/or trophectoderm biopsy before embryo transfer.Preimplantation genetic testing for aneuploidy (PGT-A) has been proven to improve the selection of embryos for transfer and therefore also assisted reproductive technology (ART) cycles. In this chapter we describe the current gold standard platform for PGT-A, next generation sequencing (NGS) protocol used in our laboratory.
Impact of preimplantation genetic testing for aneuploidy on obstetrical practice. [2020]To provide updated information on preimplantation genetic testing for aneuploidy (PGT-A), focusing on its implications on prenatal diagnostic approaches after transferal of mosaic aneuploid embryos.
A cost-effectiveness analysis of preimplantation genetic testing for aneuploidy (PGT-A) for up to three complete assisted reproductive technology cycles in women of advanced maternal age. [2020]Current evidence suggests that preimplantation genetic testing for aneuploidy (PGT-A) used during assisted reproductive technology improves per-cycle live-birth rates but cumulative live-birth rate (CLBR) was similar to a strategy of morphological assessment (MA) of embryos. No study has assessed the cost-effectiveness of repeated cycles with PGT-A using longitudinal patient-level data.
Non-invasive prenatal testing in the context of IVF and PGT-A. [2021]The high incidence of chromosome aneuploidy in human gametes and embryos is a major cause of in vitro fertilization (IVF) failure and miscarriage. In order to improve live birth rates with single embryo transfer, the use of preimplantation genetic testing for aneuploidy (PGT-A) has significantly increased. PGT encompasses methods that allow embryos to be tested for inherited conditions or screened for chromosomal abnormalities. However, PGT-A is a screening method and results can never be used to definitively predict the chromosomal status of the embryo and fetus. The objective of this manuscript is to review prenatal screening and diagnostic methods available in pregnancies conceived by IVF-PGT-A.
Does PGT-A affect cumulative live birth rate? [2023]Preimplantation genetic testing for the purpose of aneuploidy screening (PGT-A) has increased in use over the last decade.
Preimplantation genetic testing for aneuploidy is not related to adverse obstetric and neonatal outcomes in singleton pregnancies. [2023]What is the potential impact of preimplantation genetic testing for aneuploidy (PGT-A) on obstetric and neonatal outcomes?
A systematic review and meta-analysis: clinical outcomes of recurrent pregnancy failure resulting from preimplantation genetic testing for aneuploidy. [2023]Preimplantation genetic testing for aneuploidy (PGT-A) is an emerging technology that aims to identify euploid embryos for transfer, reducing the risk of embryonic chromosomal abnormalities. However, the clinical benefits of PGT-A in recurrent pregnancy failure (RPF) patients, particularly in young RPF patients, remains uncertain.
Exploring the efficacy and beneficial population of preimplantation genetic testing for aneuploidy start from the oocyte retrieval cycle: a real-world study. [2023]Preimplantation genetic testing for aneuploidy (PGT-A) is widely used as an embryo selection technique in in vitro fertilization (IVF), but its effectiveness and potential beneficiary populations are unclear.