P-006 MACS Vs Microfluidics Sperm Sorting FOR RAISED SPERM DNA FRAGMENTATION INDEX – A RCT

Abstract

Abstract Study question In Individuals with raised Sperm DNA Fragmentation Index (DFI), will sperm selection by magnetic activated cell sorting (MACS) or Microfluidic Sperm Sorting (MF) optimize the reproductive outcomes? Summary answer MACS or MF offer comparable outcomes. There seems no superiority between them. Individuals with raised spermDFI, MACS/MF can be considered to optimize results. What is known already It is evident that raised sperm DFI negatively affects the reproductive outcomes. Management for raised sperm DFI to optimize reproductive outcomes is still elusive. Study design, size, duration This is an ongoing Randomized Control Trial (RCT) with prior approval from institutional Ethical Committee (IEC) (ECR/1312/Inst/TG/2019). This is preliminary data of this ongoing study. Study duration 6months(July 2020–January 2021). Couples undergoing IVF stimulation with raised spermDFI were randomized into MACS(n = 75) and MF(n = 58) for sperm selection. This study also intends to look at efficiency of MACS and MF sperm sorting to reduce spermDFI post intervention. This trial is registered with Clinical Trials Registry India (CTRI) REF/2021/05/043439 Participants/materials, setting, methods Couples with one failed IVF were offered sperm DFI. Individuals with sperm DFI>30% were recruited. Sperm DFI testing was done with SCSA method and randomized using software. Sperm processing done with MACS or MF based on randomization on the day of Oocyte Retrieval(OPU). MACS/MF sperm processing done as per manufacturer’s instructions. Culture done till blastocyst stage and freeze all policy followed. Two Blastocysts that showed100% survival was transferred in a Frozen Embryo transfer (FET) cycle. Main results and the role of chance Implantation rates(IR) Miscarriage Rates (MR), Multiple Pregnancy Rates(MPR) Live Birth rates (LBR) were compared between groups Reduction in sperm DFI value between MACS and MF was also evaluated In MACS arm - 75 subjects recruited, 49 patients (65%) had atleast 2 blastocysts frozen and underwent FET. 26 patients (35%) had cancelled cycles due to no blastocyst formation. In MF arm - 58 subjects recruited 38 patients (65%) had atleast 2 blastocysts and underwent FET. 20 patients (35%) had cancelled cycles due to no blastocyst formation. Sperm DFI reduction with MACS Vs MF Sperm Sorting 83% of men had sperm DFI value reduced to < 30% post MACS intervention 87% of men had sperm DFI value reduced to < 30% post MF intervention Both MACS and MF seem to be efficient in sorting sperm with raised DFI and separate sperms with good DNA quality Reproductive Outcomes of MACS Vs MF Sperm Sorting were IR - 50% Vs 48% (p = 0.8540) MR - 5.3% Vs 11% (p = 0.3280) MPR - 8% Vs 18% (p = 0.1624) LBR per ET cycle - 63% Vs 63% (p = 1.0000) Reproductive Outcomes of MACS and MF sperm Sorting seems to be comparable. Data from this study doesn’t prove superiority of one processing method over another Limitations, reasons for caution This is an ongoing study and the data presented here is the preliminary data with small sample size Wider implications of the findings Optimal intervention for management of raised spermDFI needs further research. However, MACS/MF both are non invasive and seem to optimize reproductive outcomes. Nevertheless while offering these sperm sorting methods aspects like cost, time taken to process and technical challenges if any, should be considered and offered with appropriate counselling. Trial registration number REF/2021/05/043439