Abstract：
OBJECTIVE: To compare the euploidy rates among blastocysts created from sibling oocytes injected with sperm and processed using microfluidics or density gradient centrifugation.
METHODS: Sibling oocyte randomized controlled trial.
METHODS: Single university-affiliated infertility practice.
METHODS: A total of 106 patients aged 18-42 years undergoing fresh in vitro fertilization treatment cycles with preimplantation genetic testing between January 2021 and April 2022 contributed 1,442 mature oocytes, which were injected with sperm and processed using microfluidics or density gradient centrifugation.
METHODS: The sperm sample is divided and processed using a microfluidics device and density gradient centrifugation for injection into sibling oocytes.
METHODS: The primary outcome was the embryo euploidy rate. Secondary outcomes included fertilization, high-quality blastulation, and ongoing pregnancy rates.
RESULTS: The blastocyst euploidy rate per mature oocyte was not significantly different in the study group compared with the control group (22.9% vs. 20.5%). The blastocyst euploidy rate per biopsied embryo was also similar between the 2 groups (53.0% vs. 45.7%). However, the fertilization rate per mature oocyte injected was found to be significantly higher in the study group compared with the control group (76.0% vs. 69.9%). The high-quality blastulation rate per mature oocyte injected was similar between the 2 groups, as was the total number of embryos frozen. There were no differences in the number of participants with no blastocysts for biopsy or the number of participants with no euploid embryos between the 2 groups. Among the male factor infertility and recurrent pregnancy loss subgroups, there were no differences in euploidy rates, fertilization rates, blastulation rates, or total numbers of blastocysts frozen, although the study was underpowered to detect these differences. Seventy-seven patients underwent frozen embryo transfer; there were no significant differences in pregnancy outcomes between the 2 groups.
CONCLUSIONS: Microfluidics processing did not improve embryo euploidy rates compared with density gradient centrifugation in this sibling oocyte study, although fertilization rates were significantly higher.
BACKGROUND: NCT04744025.
METHODS: Sibling oocyte randomized controlled trial.
METHODS: Single university-affiliated infertility practice.
METHODS: A total of 106 patients aged 18-42 years undergoing fresh in vitro fertilization treatment cycles with preimplantation genetic testing between January 2021 and April 2022 contributed 1,442 mature oocytes, which were injected with sperm and processed using microfluidics or density gradient centrifugation.
METHODS: The sperm sample is divided and processed using a microfluidics device and density gradient centrifugation for injection into sibling oocytes.
METHODS: The primary outcome was the embryo euploidy rate. Secondary outcomes included fertilization, high-quality blastulation, and ongoing pregnancy rates.
RESULTS: The blastocyst euploidy rate per mature oocyte was not significantly different in the study group compared with the control group (22.9% vs. 20.5%). The blastocyst euploidy rate per biopsied embryo was also similar between the 2 groups (53.0% vs. 45.7%). However, the fertilization rate per mature oocyte injected was found to be significantly higher in the study group compared with the control group (76.0% vs. 69.9%). The high-quality blastulation rate per mature oocyte injected was similar between the 2 groups, as was the total number of embryos frozen. There were no differences in the number of participants with no blastocysts for biopsy or the number of participants with no euploid embryos between the 2 groups. Among the male factor infertility and recurrent pregnancy loss subgroups, there were no differences in euploidy rates, fertilization rates, blastulation rates, or total numbers of blastocysts frozen, although the study was underpowered to detect these differences. Seventy-seven patients underwent frozen embryo transfer; there were no significant differences in pregnancy outcomes between the 2 groups.
CONCLUSIONS: Microfluidics processing did not improve embryo euploidy rates compared with density gradient centrifugation in this sibling oocyte study, although fertilization rates were significantly higher.
BACKGROUND: NCT04744025.
摘要：
目的：比较从微流体或密度梯度离心处理的精子注射的同胞卵母细胞产生的胚泡的整倍体率。
方法：同胞卵母细胞随机对照试验。
方法：单身大学附属不孕症实践。
方法：在2021年1月至2022年4月期间，106名年龄在18-42岁之间接受新鲜体外受精（IVF）周期并进行植入前遗传学测试（PGT）的患者贡献了1442个成熟卵母细胞，这些卵母细胞注射了通过微流体或密度梯度离心处理的精子。
方法:精子样品通过微流体装置和密度梯度离心进行分配和处理,用于注射到同胞卵母细胞中。
方法：主要结果是胚胎整倍体率。次要结果包括受精，高质量的囊胚形成，和持续的怀孕率。
结果：与对照组相比，研究组中每个成熟卵母细胞的囊胚整倍体率没有显着差异（22.9％对20.5％，p=0.60）。每个活检胚胎的囊胚整倍体率在两组之间也相似（53.0％对45.7％，p=0.34）。然而,与对照组相比，研究组注射的每成熟卵母细胞的受精率明显更高（76.0％对69.9％，p=0.03)。两组注射每成熟卵母细胞的高质量囊胚率相似，冷冻胚胎的总数也是如此。两组之间没有进行活检的囊胚的参与者数量或没有整倍体胚胎的参与者数量没有差异。在男性因素不育症和复发性妊娠丢失亚组中，整倍体率没有差异，受精率,囊胚率,或冷冻的囊胚总数，尽管这项研究在检测这些差异方面能力不足。77例患者接受了冷冻胚胎移植；两组的妊娠结局没有显着差异。
结论：在这项同胞卵母细胞研究中，与密度梯度离心相比，微流体处理没有提高胚胎整倍体率，尽管受精率明显更高。
方法：同胞卵母细胞随机对照试验。
方法：单身大学附属不孕症实践。
方法：在2021年1月至2022年4月期间，106名年龄在18-42岁之间接受新鲜体外受精（IVF）周期并进行植入前遗传学测试（PGT）的患者贡献了1442个成熟卵母细胞，这些卵母细胞注射了通过微流体或密度梯度离心处理的精子。
方法:精子样品通过微流体装置和密度梯度离心进行分配和处理,用于注射到同胞卵母细胞中。
方法：主要结果是胚胎整倍体率。次要结果包括受精，高质量的囊胚形成，和持续的怀孕率。
结果：与对照组相比，研究组中每个成熟卵母细胞的囊胚整倍体率没有显着差异（22.9％对20.5％，p=0.60）。每个活检胚胎的囊胚整倍体率在两组之间也相似（53.0％对45.7％，p=0.34）。然而,与对照组相比，研究组注射的每成熟卵母细胞的受精率明显更高（76.0％对69.9％，p=0.03)。两组注射每成熟卵母细胞的高质量囊胚率相似，冷冻胚胎的总数也是如此。两组之间没有进行活检的囊胚的参与者数量或没有整倍体胚胎的参与者数量没有差异。在男性因素不育症和复发性妊娠丢失亚组中，整倍体率没有差异，受精率,囊胚率,或冷冻的囊胚总数，尽管这项研究在检测这些差异方面能力不足。77例患者接受了冷冻胚胎移植；两组的妊娠结局没有显着差异。
结论：在这项同胞卵母细胞研究中，与密度梯度离心相比，微流体处理没有提高胚胎整倍体率，尽管受精率明显更高。
