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1 [1] (January 6, 2026)

handle is hein.crs/govetdc0001 and id is 1 raw text is: Congressional Research Service Informing the IegisI9tive debate since 1914 B January 6, 2026 Assisted Reproductive Technology Regulation and Oversight There has been growing interest from Congress and the Trump Administration in the availability and regulation of infertility services in the United States, which include assisted reproductive technologies (ART). Fertility clinics, embryology and clinical laboratories, and health care providers providing these services in the United States are subject to regulation and oversight at both federal and state levels. This In Focus describes ART, the entities involved, and mechanisms of selected federal and state oversight of such entities. Assisted Reproductive Technology The term assisted reproductive technology (ART) refers to treatments or procedures to help achieve a pregnancy in which human oocytes or embryos are handled outside the body. Individuals or couples may seek ART for a variety of reasons, including to address infertility. Infertility is a reproductive health disorder generally defined as the inability to achieve a successful pregnancy after a certain time period of attempting to become pregnant. The most common ART procedure is in vitro fertilization (IVF), but also includes gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT). IVF consists of several steps and can be referred to as an ART cycle. The basic procedures of an ART cycle typically include * Ovarian Stimulation - A female patient is prescribed medications which stimulate her ovaries to prepare to produce multiple oocytes (human eggs). * Oocyte Retrieval - The resulting oocytes are removed from the ovaries before ovulation occurs during a surgical procedure at a fertility clinic. These retrieved oocytes might then be frozen for future use. * Fertilization of the Oocytes - The retrieved oocytes are either thawed and combined with sperm or, shortly after retrieval, combined with sperm in an embryology laboratory with the purpose of fertilizing the oocytes to develop into an embryo. * Embryo Culture - The fertilized oocytes are cultured in the laboratory to develop into embryos. Embryos that develop appropriately are then prepared for transfer or frozen for later use. * Embryo Transfer - An embryo, either fresh or frozen, can then be transferred into the uterine cavity. This may result in a pregnancy if the embryo successfully attaches to the uterine lining. ART cycles can involve other procedures or variations of the procedures briefly summarized above, depending on factors like an infertility diagnosis or whether donated material is being used. Multiple treatment cycles may be needed to achieve a successful pregnancy. Infertility can be influenced by age, reproductive organ damage, hormone imbalance, genetic disorders, or certain medical treatments. Treatments for infertility thus may involve other non-ART services such as surgery, hormone or other medication therapy, genetic counseling, or medical procedures in which only sperm are handled such as intrauterine insemination (IUI). Regulation and Oversght of'ART Entities The provision of ART services involves multiple entities, which the federal government regulates in various capacities. These include fertility clinics, embryology and clinical laboratories, and the health care professionals providing ART services. These entities are subject to federal oversight and regulation specific to the ART services they provide. Fertility Clinics ART services are provided at specialized clinics, often referred to asfertility clinics. According to the most recently published annual report, in 2021 there were roughly 500 fertility clinics operating in the United States. Fertility clinics are required to follow ART-specific federal requirements established under the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA, P.L. 102- 493). The Centers for Disease Control and Prevention (CDC) conducts the data standardization and reporting requirements under FCSRCA for all fertility clinics in the United States. According to FCSRCA (42 U.S.C. §§263a- 1-263a-7), fertility clinics that provide any treatments or procedures which include the handling of human oocytes or embryos, are required to annually report ART cycle characteristics and outcomes and which embryology laboratories the clinic works with to the CDC. The CDC collects this data through the National ART Surveillance System (NASS), a web-based data collection system. The CDC aggregates this data into an annual report: Assisted Reproductive Technology Fertility Clinic National Summary Report. The annual report for 2021 included data from 453 clinics which reported roughly 414,000 ART cycles were performed resulting in 92,000 live births, roughly 2.5% of all births in the United States that year. The number of ART cycles and resulting live births has been steadily increasing over time, with the number of annual ART cycles more than doubling over the last decade according to the 2021 annual report. All U.S. fertility clinics and their associated embryology laboratories are listed in the annual report. In 2021, roughly 50 clinics did not submit data to the CDC or did not approve their data to be included in the report. The main purpose of the ART report is to inform patients, and the focus is on success rates resulting in live births. Fertility clinics have an incentive to report to show