Effect of Microfluidic Sperm Separation vs. Standard Sperm Washing Processes on Laboratory Outcomes and Clinical Pregnancy Rates in an Unselected Patient Population

Abstract

A prospective, multicenter, randomized, sibling oocyte study was conducted with 86 couples to evaluate if a microfluidic sperm separation device improved ICSI sperm selection and subsequent cycle outcomes of fertilization, blastocyst utilization, ploidy, and clinical pregnancy rate when applied to a general patient population. Patients with at least 10 metaphase II oocytes were enrolled in the study and sibling oocyte groups were split in half. One half of the oocytes underwent ICSI with the control processed sperm and the other half were injected with sperm sorted by the ZyMōt microfluidic sperm separation device. Fertilization rate was recorded and resulting blastocysts were biopsied and evaluated for ploidy status with NGS. Euploid, non-mosaic embryos were randomly selected for single embryo transfer. A total of 787 oocytes were evaluated in the ZyMōt group and 777 in the control group. No statistical differences were observed between ZyMōt and control processing methods in any of the study outcomes evaluated. It is possible that the selection of normal, progressive sperm for ICSI, and the repair capacity of oocytes are sufficient to promote normal embryonic development in the general infertility population.

Does microfluidic sperm selection improve clinical pregnancy and miscarriage outcomes in assisted reproductive treatments? A systematic review and meta-analysis

“…This study assessed clinical pregnancy outcomes [29,30,[34][35][36][37][38][39][40][41], miscarriage outcomes [29,34,36,[38][39][40][41], and other laboratory outcomes, including fertilization [29-32, 35-37, 39, 41, 42], cleavage [29,31], total blastocysts [29][30][31][32][33]39], high-quality blastocysts [29,31,37], and euploid blastocysts [30].…”

“…Of the 13 selected studies, six took place in Turkey [29,31,34,35,40,41], three in the United States [30,36,38], one each in India [39], Spain [33], Japan [32], and Iran [37].…”

“…The utmost quality of evidence was given to studies that employed sibling oocytes for their experimental design [29][30][31][32][33]. Twelve of the studies adopted a prospective and randomized methodology [29][30][31][32][33][34][35][36][37][38][39][40], while a single study was retrospective and non-randomized [41] No study was wholly omitted during the sensitivity analysis. Given that these are random effects, the scatter plot was solely utilized to evaluate the variance between studies, and none were removed based on their positioning (S1 Fig).…”

Causes of Infertility: Diagnosis and Management With Microfluidic Sperm Sorter

“…Sperm with improved motility and dramatically reduced DNA fragmentation are produced using a microfluidic system for sperm sorting. With little effort on the part of the technician, the device produces a highly motile population of sperm [ 13 ].…”

“…This platform can also tell you how many motile and immotile sperm there are [ 12 ]. Improved laboratory and clinical outcomes have been reported with microfluidic sperm selection for ICSI, such as the possibility of producing more high-quality blastocysts, euploid blastocysts, and surplus high-quality blastocysts to be frozen for future use [ 13 ]. This study evaluates a couple facing infertility for two-and-a-half years with ongoing treatment with ICSI with good quality blastocyst formation using a microfluidic sperm sorter.…”