A large clinical trial across ten UK fertility centres is testing whether selecting sperm by their ability to bind to hyaluronic acid—a natural substance found around the egg—can increase live birth rates and reduce miscarriages in couples undergoing ICSI for male factor infertility. Current sperm selection for ICSI relies on a synthetic substance called polyvinylpyrrolidone, which slows sperm down so embryologists can pick one for injection. But this method does not assess sperm quality at a molecular level. The trial directly compares the two selection techniques in a randomised, controlled design, with the aim of determining whether hyaluronic acid binding—which mimics the natural selection process inside the body—leads to better embryos and more successful pregnancies. If the hyaluronic acid method proves superior, it could become a straightforward, low-cost change to routine IVF practice. For the roughly one in six couples affected by infertility, this could mean fewer failed cycles, fewer miscarriages, and more families taking home a healthy baby. The trial also tracks miscarriage rates and preterm labour, so safety is monitored throughout.
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RESEARCH DESIGN: Patients randomized into two equally sized groups for sperm selection by either Hyaluronan binding (PICSI) or standard polyvinylpyrrolidone (PVP). POPULATION: Patients undergoing IntraCytoplasmic Sperm Injection (ICSI) procedures for male factor infertility at the IVF units in 10 UK centres (Leeds, Sheffield, Manchester, Dundee, Liverpool, London Guy's, London Barts, Birmingham, Aberdeen and Southampton). PLANNED INTERVENTIONS: Men recruited into the study will be assessed for sperm hyaluronan binding using a proprietary assay kit (Hydak HBA slide). A single sperm will be injected directly into the egg following capture by PICSI or PVP. The clinical embryologist will monitor formation of pronuclei and cell division. High-grade embryos will be transferred into recipient partners and the management of the patient will then return to the clinical consultant for follow-up. ASSESSMENT AND FOLLOW-UP: Efficacy determined by comparison of outcomes from PICSI and PVP-selected sperm as follows: Biochemical pregnancy (BP) at 7 days post embryo transfer (pET); Ultrasound detection of fetal sac and/or heartbeat at 6-8 weeks (CP); Live birth rate (LBR) at > or =37 weeks (reported per first cycle and per couple). Safety will be assessed at all times during follow up by recording miscarriage and preterm labour rates throughout. Patient (and fetal) safety will be closely monitored and clear trial stopping criteria will be in place. PROPOSED SAMPLE SIZE: With 90% power (p=0.05), a minimum of 3266 couples (1633 in each arm) is required to detect a 5% improvement in LBR (24% - 29% per cycle), falling to 852 couples (426 in each arm) at 10.0% improvement. We aim to recruit 3730 couples into the study over 24 months. STATISTICAL ANALYSIS: Descriptive statistics will be recorded for Biochemical (BPR), Clinical (CPR), Live Birth (LBR) rates and pregnancy loss. Statistical tests will look for significant differences between the control and interventional trial arms for each of these outcome measures in relation to rates of DNA fragmentation and chromatin compaction of sperm in (i) high v low Hyaluronan Binding Score (BPS); (ii) CPR, LBR and pregnancy loss. Structural equation modelling will be used to probe these relationships for evaluation of mechanism. TIMETABLE: 6 months set up, recruitment is estimated at 1864 PA (40% of total eligible ICSI patients over 10 centres), requiring 24 months. Mechanistic evaluation will take 24 months running concurrently. Follow up for 10 months to include capture of Live Birth Data. Study completed , main outcomes analysed and final report available at 42 months.
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