Importance: Intracytoplasmic sperm injection (ICSI) is increasingly used in patients without severe male factor infertility without clear evidence of a benefit over conventional in vitro fertilization (IVF).
Objective: To assess national trends and reproductive outcomes for fresh IVF cycles (embryos transferred without being frozen) following the use of ICSI compared with conventional IVF with respect to clinical indications for ICSI use.
Design, setting, and population: Retrospective cohort study using data on fresh IVF and ICSI cycles reported to the US National Assisted Reproductive Technology Surveillance System during 1996-2012.
Main outcomes and measures: Trends in ICSI use during 1996-2012 with respect to male factor infertility, unexplained infertility, maternal age 38 years or older, low oocyte yield, and 2 or more prior assisted reproductive technology cycles; reproductive outcomes for conventional IVF and ICSI cycles during 2008-2012, stratified by the presence or absence of male factor infertility.
Results: Of the 1,395,634 fresh IVF cycles from 1996 through 2012, 908,767 (65.1%) used ICSI and 499,135 (35.8%) reported male factor infertility. Among cycles with male factor infertility, ICSI use increased from 76.3% (10,876/14,259) to 93.3% (32,191/34,506) (P < .001) during 1996-2012; for those without male factor infertility, ICSI use increased from 15.4% (4197/27,191) to 66.9% (42,321/63,250) (P < .001). During 2008-2012, male factor infertility was reported for 35.7% (176,911/494,907) of fresh cycles. Among those cycles, ICSI use was associated with a lower multiple birth rate compared with conventional IVF (30.9% vs 34.2%; adjusted relative risk [RR], 0.87; 95% CI, 0.83-0.91). Among cycles without male factor infertility (n = 317,996), ICSI use was associated with lower rates of implantation (23.0% vs 25.2%; adjusted RR, 0.93; 95% CI, 0.91-0.95), live birth (36.5% vs 39.2%; adjusted RR, 0.95; 95% CI, 0.93-0.97), and multiple live birth (30.1% vs 31.0%; adjusted RR, 0.93; 95% CI, 0.91-0.95) vs conventional IVF.
Conclusions and relevance: Among fresh IVF cycles in the United States, ICSI use increased from 36.4% in 1996 to 76.2% in 2012, with the largest relative increase among cycles without male factor infertility. Compared with conventional IVF, ICSI use was not associated with improved postfertilization reproductive outcomes, irrespective of male factor infertility diagnosis.