The efficacy of the new embryo culture medium which designed from the components of human tubal fluid; prospective randomized trial

Sequential and single step media are the most widely used for embryo cultures in IVF. There is no medium which designed from human oviductal fluid. Almost all media that available to use at present are derived and arranged from previous somatic cell culture media. In 2017, the medium (HiGROW OVIT; Fuso Pharma, Japan) composed of amino acid concentrations by the data of human oviductal fluid became available to use in Japan, which contained different concentrations of amino acids from previous media. In this study, we examine the clinical availability of the new media in terms of utilization of embryos and giving birth to healthy baby in IVF. prospective randomized trial. Human oviductal fluid was aspirated laparoscopically from 28 women aged 26–39 years with no major intrapelvic abnormality to formulate new embryo culture medium. Liquid chromatography with tandem quadruple mass spectrometry and ion chromatography were used to analyze 31 components of the oviductal fluid sample. We conducted an RCT to evaluate the medium using 3,418 embryos obtained from 674 cycles of patients who underwent IVF or intracytoplasmic sperm injection (ICSI) between September 2017 and March 2019. Before fertilization, the oocytes were divided into two groups: cultures using the new medium composed of human oviductal amino acid (OVIT); and cultures using current medium (Medium A). The embryo grade during culture period to the blastocyst stage and clinical outcome after embryo transfer were compared between the OVIT group and the Medium A group. Between the two groups, patient characteristics were not significantly different. The number of embryos in the OVIT group on day 3 which showed “8-cell 2-grade” by Veeck’s criterion, was larger (18.6% (318/1,709)) than in the Medium A group (14.1% (241/1,709)); P<0.01. The OVIT group showed significantly higher rates of blastocyst development (62.4% (1,024/1,641)) than the Medium A group (58.5% (961/1,643)); P<0.05). The number of embryos which were elected for ET or cryopreserved was larger in the OVIT group (44.4% (759/1,709)) compared with the Medium A group (37.2% (636/1,709)); P<0.01. Furthermore, in the OVIT group had higher implantation rates (28.1% (124/442)) after ET than that in the Medium A group (25.5% (94/368); the difference was not statistically different. Birth weight of the OVIT group was 3,179.2±473.3 grams (n=39) and the Medium A group was 3,087.1±409.1 grams (n=28). The ratio of male to female was 20/19 in the OVIT group (n=39), and 10/16 in the Medium A group (n=26). One trismus nascentium child was confirmed in the OVIT group and one congenital ear fistula child was confirmed in the Medium A group. Medium composed of human oviductal amino acids enhances embryonic ability more than the current single step medium, and it may make a contribution to clinical success in IVF treatment.