[Intracytoplasmic injection of spermatozoa (ICSI). Ethical requirements and assessment]

There is no doubt that the clinical application of intracytoplasmic sperm injection (ICSI) has been a major breakthrough in the treatment of extremely severe male-factor infertility. We analyzed the impact of ICSI on medically assisted reproduction practices. The potential of risks ICSI, whether related to abnormalities associated with male infertility, penetration within the ovocyte or the risk of introducing foreign material, should not be neglected. With ICSI, a situation of human experimentation has been created without adequate prior animal experimentation and research has been conducted without the approval of ethics committees as required by the Huriet Law in France. When first introduced, ICSI was not accompanied by an evaluation protocol to follow the biological risks and societal impact. We thus believe that meeting the requirements of the following ethical criteria deserves discussion. ICSI should still be considered as an experimental clinical procedure. Risk should be evaluated with animal models since all forms of spermatozoa can now be injected into mouse oocytes. Complete independence is needed for biological and genetic assessment, pediatric follow-up on children born and societal and health care impact. Scientific personnel as well as patients and the society in general should be continuously informed of the status of the evaluation work. As for any experimental therapy, the process of obtaining informed consent takes on special significance. Careful explanation of the procedure is needed so the patients can be in a position to determine what level of risk is acceptable.