L26/P-030 Microfluidic sperm sorting versus double density gradient preparation in intrauterine insemination: randomized and real-world clinical outcomes

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Abstract Study question Does microfluidic sperm sorting (MFSS) improve clinical-pregnancy and live-birth outcomes in intrauterine-insemination(IUI) compared with conventional double density gradient(DDG) sperm preparation across different clinical IUI settings? Summary answer MFSS did not improve live-birth rates versus DDG, but adjusted analyses showed non-inferior reproductive outcomes, no adverse trends, and practical laboratory advantages in clinical practice. What is known already IUI remains a widely used, cost-effective first-line fertility treatment. Sperm preparation plays a key role in determining IUI success, with DDG being the most used method. Microfluidic sperm sorting is a centrifugation-free technique designed to select progressively motile sperm and reduce handling related stress. While MFSS has shown promise in advanced ART settings, evidence supporting its clinical effectiveness in IUI remains limited. Study design, size, duration This prospective single-centre study was conducted between April 2024-December 2025 and comprised three linked analyses: 1. A randomized-controlled-trial (RCT)comparing-MFSS with DDG in first IUI-cycles (MFSS n = 121; DDG n = 110); 2. A sequential-cohort of 209-women undergoing-MFSS-prepared-IUI following one failed DDG-IUI-cycle. 3. An observational comparison of donor sperm-IUI-cycles using MFSS(n = 647)/DDG(n = 906). Women21–35years with at least-one patent tube, normal-uterine-cavity, and total motile sperm count >10 million were included. Cycles with poor ovarian response or > 2 dominant follicles were excluded Participants/materials, setting, methods All participants underwent controlled ovarian stimulation using standardized clinic protocols with ultrasound monitoring, followed by ovulation trigger and timed intrauterine insemination. Sperm preparation was performed using either conventional density gradient centrifugation or microfluidic sperm sorting using a commercially available device . Uniform luteal phase support was provided. Primary outcomes were clinical pregnancy and live birth rates. Multivariable logistic regression adjusted for female age, infertility duration, follicle number, and post-wash total motile sperm count. Main results and the role of chance Baseline female age, male age, and infertility characteristics were comparable between MFSS and DDG groups in the randomized cohort. MFSS resulted in significantly higher post-processing progressive motility compared with DDG (92.8% vs 70.5%, p < 0.0001), while post-processing sperm concentration was higher following DDG preparation (p = 0.004). Post-wash total motile sperm count remained adequate for IUI in both groups. In the RCT, CPR was 12.4% with MFSS and 10.0% with DDG, with corresponding LBRs of 12% and 10%, respectively; no miscarriages were observed. Differences were not statistically significant. In the sequential cohort of women undergoing MFSS after one failed DDG-IUI cycle, CPR and LBR were both 9.5%, with no reported miscarriages, indicating preservation of reproductive outcomes without a demonstrable rescue effect. In donor sperm IUI cycles, CPR was 13% with MFSS and 14% with DDG, while LBR was 10% and 12%, respectively. Miscarriage rates were low and comparable across groups. On multivariable logistic regression adjusting for relevant confounders, sperm preparation method was not independently associated with live birth, confirming that MFSS achieved reproductive outcomes non-inferior to DDG across all clinical settings evaluated. Limitations, reasons for caution Although live birth rates were available for all analyzed cycles, extended obstetric, neonatal, and offspring outcomes were not assessed. Findings reflect single center clinical practice. Wider implications of the findings MFSS represents a clinically non-inferior alternative to conventional DDG for IUI. While it does not enhance live birth outcomes, MFSS maintains comparable reproductive results while offering a simpler, centrifugation-free, and less operator-dependent laboratory workflow. These operational advantages may be relevant in selected clinical and laboratory settings. Trial registration number Yes

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