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5. Innovation in Assisted Reproduction
- Johns Hopkins University Press
- Chapter
- Additional Information
the background Assisted reproductive technology (ART) had its start in the 1970s and, according to estimates by the Centers for Disease Control and Prevention (CDC), since 1978 approximately 0.9 percent of all U.S. births and more than one million children worldwide have been conceived with ART procedures. Until the late 1980s, assisted reproductive technology was successful only 10 percent of the time. However, by 2000, success rates were slightly more than 35 percent for the 383 U.S. clinics reporting data to the CDC (99,639 ART cycles resulted in 35,025 live babies born). The perceived safety and success of assisted reproductive technology has led to an increasing demand for its use. Responding to the demand, the number of fertility specialists and clinics has grown, increasing the competition for patients. This competition has led to assertive marketing of fertility services to referring doctors and directly to consumers, as well as to reductions in cost, with some clinics o=ering financing programs and moneyback guarantees. In the United States, the infertility treatment industry grosses $2 billion per year, with couples paying up to $200,000 to achieve a single pregnancy (Andrews 1999; Kolata 2002; Centers for Disease Control and Prevention 2003). The field of assisted reproductive technology is noted for its constant innovations . It started with in vitro fertilization, or IVF, treatment.1 Over time, IVF has been modified with techniques such as gamete intrafallopian transfer (GIFT),2 zygote intrafallopian transfer (ZIFT),3 and intracytoplasmic sperm injection (ICSI).4 Innovation in Assisted Reproduction chapter five Because 50 to 80 percent of embryos produced via IVF have been chromosomally abnormal, preimplantation genetic diagnosis was recently introduced, and this development has also significantly advanced the field. In preimplantation genetic diagnosis, a technician removes a cell or two from the developing embryos and tests for the sex of the embryo and for genetic abnormalities, so that only embryos free of certain sex-linked or genetic defects are used to impregnate the mother. To accomplish these ART procedures, highly sophisticated and microminiaturized tools and special culture media and freezing techniques have been developed ; highly skilled technicians are required to perform the work. Frequently the new tools are made in the lab of the innovator. Also, the procedural innovations are introduced as practice modifications rather than as controlled research, in part because U.S. laws forbid any federal agency to fund research involving human embryos. The political climate surrounding assisted reproductive technology has left it without federal regulation in the United States except for mandatory reporting of pregnancy success rates, which has been criticized as unveri- fied, inconsistent, and unreliable. Neither are there comprehensive or specific state regulations. Instead, the field is guided by voluntary and unenforced professional standards published by two professional societies, the American Society of Reproductive Medicine and the American College of Obstetricians and Gynecologists. These guidelines specify minimum standards for IVF and some other related procedures, and these standards have been cited in some but not all medicolegal settings as the standard of care. Many of the physicians (it is di;cult to learn how many) who practice IVF are board certified in reproductive endocrinology and infertility. The ART labs are also usually (again, the number is uncertain) certified under general laboratory procedure standards and, depending on the circumstances and the jurisdiction, under tissue bank regulations. There is, as well, the voluntary Reproductive Laboratory Accreditation Program, which has developed guidelines for lab personnel qualifications, resource and facility requirements, quality control and assurance , record keeping, and proficiency testing. In addition, most IVF practitioners participate in the Society for Assisted Reproductive Technologies, which maintains a registry on the outcomes of ART procedures and periodically analyzes the registry data to develop further practice recommendations. Whether assisted reproductive technology should be regulated any further is the subject of ongoing debate. Proponents see the need to curb irresponsible use of unproven techniques and to ensure proper consent. Opponents, including some infertility advocacy groups, fear that legislation and regulation will interINNOVATION IN ASSISTED REPRODUCTION 73 [3.237.178.126] Project MUSE (2024-03-28 15:09 GMT) fere with medical practice and patients’ rights, increase the cost of treatment, limit access to treatment, and politicize medical and personal choices (Adamson 2002; Marcus 2002). Given the nature of in vitro fertilization (treatment cycles take more than a month, a pregnancy takes nine months, and the children produced take years to mature), understanding whether treatment modifications have succeeded...