Study question What is the effectiveness of swim-up (SU) and density gradients (DG) for sperm preparation in infertile couples undergoing intrauterine insemination (IUI)? Summary answer In couples undergoing IUI, there is no significant difference in the treatment outcomes between SU and DG. What is known already Swim-up (SU) and density gradients (DG) are the most two commonly used techniques for sperm preparation in intrauterine insemination (IUI). The latest Cochrane review concluded that there is uncertainty about the effectiveness of SU versus DG and no studies reported on live birth. Study design, size, duration This open-label, multi-centre randomised clinical trial was conducted on 912 infertile couples at a tertiary IVF center, Ho Chi Minh City, Vietnam from August 2020 to June 2023. Couples were randomly asigned to two groups, SU and DG using computerized randomisation on the day of IUI with variable block size of 2, 4 or 6. Primary outcome was live birth rate. Participants/materials, setting, methods Infertile couples were eligible if aged ≥18, indicated for IUI with ≤2 IUI prior attempts and husbands’ sperm concentration ≥5x106/ml, progressive motility (PR) ≥32% and total PR sperm count >5x106 before sperm preparation (WHO 2010 criteria). Couples using frozen semen, or high viscosity semen were not eligible. Women had ovulation induction using hMG. Sperm preparation was performed within one hour after ejaculation. IUI was performed once at 36 to 40 hours after hCG trigger. Main results and the role of chance Between August 2020 and June 2023, 912 couples were randomly assigned to SU (n = 456) or DG (n = 456). Baseline characteristics were comparable between the two groups (mean female age of 31.3 ± 0.4 years; total sperm count: 86.2 [52.9;137.6] million; sperm motility: 44.8 ± 8.2%). Live birth occurred in 55 (12.1%) couples in the SU group and 71 (15.7%) couples in the DG group (RR 0.77; 95% CI 0.56-1.07). Ongoing pregnancy and multiple pregnancy were also comparable between the two groups. There were no statistically significant differences between the SU and DG groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications. Pre-planned subgroup analysis showed that the live birth rate was not materially affected by the IUI indications, total motile sperm after preparation (<1, ≥1 and <5, ≥5 and <10 and ≥10 million). Limitations, reasons for caution The main limitation of the study was its open-label design, due to the nature of the interventions. Wider implications of the findings Our study suggests that in couples undergoing IUI with progressive motility (PR) ≥32% and total PR sperm count >5x106 before sperm preparation, SU or DG can both be used for sperm preparation, with a preference for density gradients. Trial registration number NCT04477356

中文翻译：

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O-017 宫内授精中精子制备的游泳与密度梯度：一项多中心随机临床试验


研究问题 对于接受宫内授精 (IUI) 的不孕夫妇来说，游泳 (SU) 和密度梯度 (DG) 对精子制备的有效性如何？总结答案 在接受 IUI 的夫妇中，SU 和 DG 的治疗结果没有显着差异。众所周知，游泳（SU）和密度梯度（DG）是宫内授精（IUI）中最常用的两种精子制备技术。最新的 Cochrane 综述得出的结论是，SU 与 DG 的有效性存在不确定性，并且没有关于活产的研究报告。研究设计、规模、持续时间 这项开放标签、多中心随机临床试验于 2020 年 8 月至 2023 年 6 月在越南胡志明市三级 IVF 中心对 912 对不孕夫妇进行。 SU 和 DG 在 IUI 当天使用计算机随机化，可变块大小为 2、4 或 6。主要结果是活产率。参与者/材料、背景、方法 不孕夫妇如果年龄≥18岁、之前尝试IUI次数≤2次、丈夫精子浓度≥5x106/ml、前向运动率(PR)≥32%且PR精子总数>5x106，则符合资格精子制备前（世界卫生组织 2010 年标准）。使用冷冻精液或高粘度精液的夫妇不符合资格。女性使用 hMG 诱导排卵。精子制备在射精后一小时内进行。在 hCG 触发后 36 至 40 小时进行一次 IUI。主要结果和机会的作用 2020 年 8 月至 2023 年 6 月期间，912 对夫妇被随机分配到 SU（n = 456）或 DG（n = 456）。两组之间的基线特征具有可比性（女性平均年龄为 31.3 ± 0.4 岁；精子总数：86.2 [52.9;137]。6]万；精子活力：44.8±8.2%）。 SU 组中有 55 对 (12.1%) 夫妇发生了活产，DG 组中有 71 对 (15.7%) 夫妇发生了活产（RR 0.77；95% CI 0.56-1.07）。两组之间的持续妊娠和多胎妊娠也具有可比性。 SU组和DG组在妊娠并发症、产科和围产期并发症、早产、出生体重和新生儿并发症的发生率方面无统计学差异。预先计划的亚组分析显示，活产率不受 IUI 指征、准备后活动精子总数（<1、≥1 和 <5、≥5 和 <10 和≥1000 万）的重大影响。局限性、谨慎原因 该研究的主要局限性在于其开放标签设计，这是由于干预措施的性质造成的。研究结果的更广泛影响 我们的研究表明，在精子制备前接受 IUI 且渐进性活力 (PR) ≥32% 且 PR 精子总数 >5x106 的夫妇中，SU 或 DG 均可用于精子制备，且优先考虑密度梯度。 试用注册号NCT04477356