A recent study conducted across ten reproductive centers in China suggests that the widely-used fertility treatment known as intracytoplasmic sperm injection (ICSI) may not provide better outcomes than conventional in-vitro fertilization (IVF) in cases of non-severe male infertility. The findings published in The Lancet journal are expected to influence clinical practices and patient choices by emphasizing the importance of tailoring fertility treatments to specific medical profiles.

ICSI was introduced in 1992 and was initially designed to overcome severe male infertility by directly injecting a single sperm into an egg. This method has become a common procedure throughout the globe, for severe cases and for a broader range of fertility issues, including non-severe male infertility.
The multicenter, open-label, randomized controlled trial enrolled a total of 2,387 couples dealing with non-severe male infertility. These couples were without any prior history of poor fertilization issues and were randomly assigned to undergo either ICSI or conventional IVF. The primary focus of the study was the live birth rate after the first embryo transfer.
After several screening and adjustments that included the exclusion of ineligible participants or those who withdrew consent, this study analyzed outcomes for 1,154 couples in the ICSI group and 1,175 in the conventional IVF group. The results observed from April 2018 to November 2021 revealed that the live birth rates were quite similar between the two groups. Also, 33.8% of the couples in the ICSI group and 36.6% in the IVF group achieved live births where the adjusted risk ratio was 0.92, which was not statistically significant (p=0.16).

The research also recorded neonatal mortality that marked slightly higher incidents in the ICSI group (0.2%) when compared to the IVF group (0.1%). This findings raised concerns about the risks associated with the more invasive nature of ICSI, unlike conventional IVF which involves the direct injection of sperm into the egg. Overall, the outcomes of this study advises caution in the routine use of ICSI for couples where male infertility does not reach a severe threshold.
Source:
Wang, Y., Li, R., Yang, R., Zheng, D., Zeng, L., Lian, Y., Zhu, Y., Zhao, J., Liang, X., Li, W., Liu, J., Tang, L., Cao, Y., Hao, G., Wang, H., Zhang, H., Wang, R., Mol, B. W., Huang, H., & Qiao, J. (2024). Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial. In The Lancet (Vol. 403, Issue 10430, pp. 924–934). Elsevier BV. https://doi.org/10.1016/s0140-6736(23)02416-9