BACKGROUND: Intracytoplasmic sperm injection (ICSI) was initially developed as part of in vitro fertilization (IVF) to treat male-factor infertility. However, despite the added cost, uncertain efficacy, and potential risks of ICSI, its use has been extended to include some patients without documented male-factor infertility. METHODS: We analyzed national data on assisted reproductive technology reported to the Centers for Disease Control and Prevention, to determine temporal trends in the use of ICSI and IVF in the United States, and we examined differences in the use of ICSI between states with and those without mandated insurance coverage. RESULTS: From 1995 to 2004, the number of fertility clinics and fresh-embryo cycles and the rates of IVF-related pregnancies and live births increased. The percentage of IVF cycles with the use of ICSI also increased dramatically (from 11.0% to 57.5%), while the percentage of diagnoses of infertility attributed to male-factor conditions remained stable. The ratio of ICSI procedures to diagnoses of male-factor infertility steadily increased each year, suggesting an increasing use of ICSI for conditions other than male-factor infertility. From 1999 to 2004, there was an increasing use of ICSI relative to the percentage of patients with male-factor infertility in states with and those without mandated insurance coverage. For any given year, however, states with insurance coverage had a higher ratio of ICSI use to diagnoses of male-factor infertility than did states without insurance coverage (P<0.001). CONCLUSIONS: Since 1995, the use of ICSI in the United States has increased dramatically, while the proportion of patients receiving treatment for male-factor infertility has remained stable. State-mandated health insurance coverage for IVF services is associated with greater use of ICSI for infertility that is not attributed to male-factor conditions.
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