Randomised double-blind controlled trial of non-invasive preimplantation genetic testing for aneuploidy in in vitro fertilisation: a protocol paper

Abstract

IntroductionThe success rate of in vitro fertilisation (IVF) treatment for couples with infertility remains low due to lack of a reliable tool in selecting euploid embryos for transfer. This study aims to compare the efficacy in embryo selection based on morphology alone compared with non-invasive preimplantation genetic testing for aneuploidy (niPGT-A) and morphology in infertile women undergoing IVF.Methods and analysisThis is a randomised double-blind controlled trial conducted in two tertiary assisted reproduction centres. A total of 500 infertile women will be recruited and undergo IVF as indicated. They will be randomly assigned on day 6 after oocyte retrieval into two groups: the intervention group using morphology and niPGT-A and the control group based on morphology alone. In the control group, blastocysts with the best quality morphology will be replaced first. In the intervention group, blastocysts with the best morphology and euploid result of spent culture medium will be replaced first. The primary outcome is a live birth per the first embryo transfer. The statistical analysis will be performed with the intention to treat and per protocol.Ethics and disseminationEthics approval was sought from the institutional review board of the two participating units. All participants will provide written informed consent before joining the study. The results of the study will be submitted to scientific conferences and peer-reviewed journals.Trial registration numberNCT04474522.

Advancements and Applications of Preimplantation Genetic Testing in In Vitro Fertilization: A Comprehensive Review

“…One pivotal advancement lies in developing non-invasive approaches that scrutinize cell-free DNA (cfDNA) extracted from the blastocoel or embryo culture media, thus preventing the need for invasive embryo biopsies. This innovative method facilitates the evaluation of genetic status without directly impacting the embryo, mitigating the risk of damage and enhancing the overall viability of embryos [ 58 , 59 ]. Moreover, integrating sophisticated technologies such as NGS and SNP arrays into non-invasive PGT techniques has facilitated the simultaneous assessment of monogenic and chromosomal abnormalities at heightened resolution.…”

Investigating Cytogenetic Profiles in Couples Experiencing Recurrent Implantation Failure Post<i> in vitro</i> Fertilization

“…Assisted reproduction techniques have significantly contributed to enabling conception for many infertile couples. However, despite advancements in ovarian stimulation, culture mediums, and laboratory conditions, the success rates for pregnancy and live births per transfer stand at approximately 35%-45% and 25%-36%, respectively [6,7].…”

“…Recurrent implantation failure (RIF) poses a profound challenge for both couples and medical professionals, signifying the absence of pregnancy despite the use of high-quality embryos and without discernible causes. Chromosomal aberrations constitute a leading cause of pregnancy failure, miscarriage, and congenital anomalies in both natural conception and pregnancies resulting from in vitro fertilization (IVF) [6].…”