Abstract
Study question
In Individuals with raised Sperm DNA Fragmentation Index (SDF), will sperm selection by magnetic activated cell sorting (MACS) or surgical retrieval of testicular sperms (TESA) optimize the reproductive outcomes?
Summary answer
Couples with failed implantation raised SDF, TESA /MACS offer similar results. This RCT doesn’t prove superiority or added benefit with any of the above interventions.
What is known already
It is evident that raised SDF negatively affects the reproductive outcomes. Management for raised SDF to optimize reproductive outcomes is still elusive.
Study design, size, duration
This was a Randomized Control Trial (RCT) with prior approval from institutional Ethical Committee and trial registration. Couples undergoing stimulation with raised SDF were randomized to MACS (n = 75) and TESA (n = 75) for sperm selection between April2019 & February2020.
Participants/materials, setting, methods
Couples with history of one failed IVF had SDF testing and SDF>30% were recruited. SDF test done with SCSA method and randomized using software. ICSI was the method of insemination. Extended embryo culture till blastocyst was done and freeze all policy was opted. Two Blastocysts that showed 100% survival were transferred in a Frozen Embryo transfer (FET) cycle. Embryonic and Reproductive outcomes were compared between both groups. Live birth and Miscarriage were the primary outcomes.
Main results and the role of chance
Reproductive Outcomes of MACS Vs TESA were:
Average Blastocyst conversion - 32% Vs 39% (RR 1.22, CI1.00 to 1.50)
Implantation rate (IR) - 50% Vs 35% (RR - 0.71, CI 0.51 to 0.98)
Miscarriage rate (MR) - 5.3% Vs 11% (RR1.6333, CI 0.5227 to 5.1039)
Multiple Pregnancy rate (MPR) - 8% Vs 4%
Live birth Rate (LBR) per Intention to treat (ITT) - 41.3% Vs 44% (RR 0.95, 95% CI 0.72 to 1.26)
LBR per ET cycle - 63% Vs 56% (RR 1.23, 95% CI 0.77 to 1.94)
Our preliminary results suggest that despite greater availability of blastocysts for transfer in the TESA group, no difference in ART outcomes was observed between the groups.
Though the IR was statistically low with TESA, our primary outcomes LBR and MR were comparable.
TESA or MACS seem to offer similar outcomes. Considering the invasiveness with TESA, MACS can be offered for better sperm selection for couples with raised sperm DFI & failed implantation.
Limitations, reasons for caution
Small sample size. TESA is a surgical intervention
Wider implications of the findings
Optimal intervention for management of SDF still needs further research.
Trial registration number
CTRI/2019/07/020140
DNA Fragmentation in Human Spermatozoa and Pregnancy Rates after Intrauterine Insemination. Should the DFI Threshold Be Lowered?