RAISED SPERM DNA FRAGMENTATION –RANDOMISED CONTROLLED TRIAL OF MACS VS TESA TO OPTIMISE REPRODUCTIVE OUTCOMES

Abstract

In Individuals with raised Sperm DNA Fragmentation (SDF), randomization with magnetic activated cell sorting (MACS) or surgical retrieval of testicular sperms (TESA) will it reduce SDF and optimize the reproductive outcomes? This is an ongoing Randomized Control Trial (RCT) with prior approval from institutional Ethical Committee (IEC) conducted at a Private Teaching ART Clinic. This is preliminary data of the pilot study. Study duration 7months (January – July 2019). Couples undergoing IVF stimulation with raised SDF were randomized into MACS group (n=30) and TESA group (n=30) for sperm selection. Couples with history of one failed IVF cycle were offered testing for SDF. Individuals with SDF > 30% were included in the study. SDF testing was done with SCSA method and couples randomized using software into respective intervention groups. TESA was done as per our clinic’s Standard Operating Protocol (SOP) and MACS was done as per the instruction from the manufacturer. Intra Cytoplasmic Sperm Injection (ICSI) was the method of insemination in all cases. Extended embryo culture till blastocyst stage was done and a freeze all policy was opted. Two Blastocysts that showed 100% survival were transferred in a Frozen Embryo transfer (FET) cycle. Mean of Implantation Rates (IR) and Clinical Pregnancy Rates (CPR), Miscarriage Rates (MR) & Live Birth Rates (LBR) were compared between both groups. Mean Reproductive Outcomes for MACS & TESA groups were as follows: Blastocyst formation rates – 38% Vs 31% (P=0.5717) CPR – 50% Vs 83% (P= 0.0072) IR – 43% Vs 72% (P= 0.0243) MR- 33% Vs 16% (P= 0.1290) LBR – 17% Vs 67% (P= 0.0001) Blastocyst formation was comparable between the groups; However, TESA group had significantly higher CPR, IR, LBR and lesser MR. Testicular sperm seem to have better DNA quality than ejaculated sperm. In couples with failed IVF attempts and raised SDF, we can offer TESA as an active intervention to optimize reproductive outcomes. Poor outcomes in MACS group needs further research. LIMITATIONS, REASONS FOR CAUTION: Small sample size. TESA is a surgical intervention. TESA seems like a beneficial intervention to optimize sperm selection and reproductive outcomes for Individuals with raised sperm DFI.