1. For couples with a male partner with normal sperm counts and motility, intracytoplasmic sperm injection did not result in higher rates of live birth compared with conventional in-vitro fertilization (IVF).
2. Higher rates of fertilization per oocyte retrieved and per oocyte inseminated observed in intracytoplasmic injection group with no impact on outcomes at 12 months post-randomization.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Intracytoplasmic sperm injection (ICSI) is an IVF technique initially utilized in couples with severe male factor infertility. Recently, ICSI rates have increased relative to rates of conventional IVF despite retrospective studies showing similar outcomes. Additionally, use of ICSI has increased among couples with non-male factor infertility. This open-label, multicenter, randomized control trial assessed the success of ICSI compared to conventional IVF as measured by live birth in couples with a male partner who has normal sperm counts and motility. Data from this trial demonstrate comparable rates of live birth after first embryo transfer and fertilization failure among the ICSI and conventional IVF groups. The results of this study challenge the rising trend in broad ICSI use in couples without male factor infertility. Cost and invasiveness ICSI compared to conventional techniques are additional factors for couples to consider when choosing the appropriate IVF technique.
In-Depth [randomized control trial]: This study randomized 1064 couples equally to ICSI (n=532) and conventional IVF (n=532) groups using variable block size randomization. Inclusion criteria included semen samples with normal count, motility, and morphology per WHO 2010 criteria, two or fewer prior IVF/ICSI cycles, and were not using frozen samples. Clinicians performing embryo transfer were blinded to group assignment, but patients and treating physicians were knowledgeable of group assignment. Primary outcome was defined as live birth (delivery of one baby showing any signs of life after 24 weeks gestation) after the first embryo transfer from the initiated cycle. Secondary outcomes included fertilization per oocyte inseminated or injected, abnormal oocytes, and pregnancy complication rates. At 12 months after random allocation from the initiated cycle, live birth outcomes after first embryo transfer were comparable among ICSI and conventional IVF groups (RR 1.11, 95% CI [-2.4 – 9.2], p = 0.27). Rates of fertilization per oocyte inseminated were significantly higher in the ICSI group (95% CI [2.2 – 8.6%], p = <0.0001) with lower rates of abnormal fertilization per oocyte as well (95% CI [-7.6 – -5.1%], p = <0.0001). This study is limited by a sizeable amount of patient crossover due to preference for ICSI, as well as difference in cost between the two treatment protocols, to which patients were not blinded. Despite these limitations, the results of this study challenge the use of ICSI in couples without male-factor infertility, especially with regard to resource utilization.
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