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New FDA Regulations

On May 25, 2005 new FDA regulations go into effect that will drastically change certain areas of Assisted Reproductive Technology. At PFC, we feel it is important for our patients to understand the implications of these regulations and the effect they may have on their fertility care. We have created an in-house task force to not only ensure that PFC is in compliance with these new regulations, but also to provide patients with as much information as possible. While these new FDA laws will require more time and expense on the part of patients and clinics, federal law mandates that we adhere to them. These new FDA requirements will affect the infectious disease screening of egg and sperm donors and individuals using gestational carriers. The law as currently written also will affect couples that may wish to donate their frozen embryos to another individual at some time in the future. The source of the eggs or sperm must be screened in accordance with the new rules if the eggs are retrieved or sperm collected on or after May 25, 2005 at any IVF clinic or sperm bank in the United States. In compliance with California State laws PFC currently performs infectious disease testing on all individuals involved in IVF as well as sperm donors for intrauterine insemination (IUI). The FDA regulations apply to any situation in which eggs or sperm (or the resultant embryos) from an individual are being placed into another person with whom the source is not sexually intimate. The FDA requires screening for some diseases such as Jacob-Creutzfeldt disease and cytomegalovirus that California does not. Screening involves review of medical records, an interview, physical examination and testing. The most difficult of the federal requirements is that testing must be performed within seven days of collecting the sperm or eggs. This means predicting the exact day that an egg retrieval or IUI will take place and relying upon sometimes slow outside reference laboratories to send test results back quickly. The embryo transfer or IUI CANNOT OCCUR until the results are received and the donor(s) determined to be eligible. If results are not available by the day of scheduled embryo transfer, transfer may be postponed up to day 5 (blastocyst transfer) or ultimately cancelled. The embryos would be frozen for transfer at a later date. IUI's with donor sperm would have to be cancelled if results are not available. In an effort to minimize the likelihood that a retrieval or IUI will be cancelled and to maintain compliance with FDA and California regulations, PFC will continue to perform infectious disease testing on ALL IVF patients, egg donors and sperm sources (IVF & IUI) prior to cycle commencement. Individuals subject to FDA screening will complete the infectious disease questionnaire and physical examination. Within seven days of the anticipated egg retrieval or IUI, a second set of infectious disease tests will be done. Sperm sources will be requested to freeze a sperm sample within seven days of the initial screening as backup in case the second set of tests are not available on the day of retrieval or IUI. For couples wishing to maintain the option of donating their embryos in the future, the egg and sperm sources will need to be retested six or more months after the egg retrieval. PFC staff are working to identify outside reference laboratories that meet the FDA criteria and that will provide quick turn around time at reasonable cost to our patients. Your clinical coordinator in conjunction with the PFC FDA Task Force will address any concerns you may have on this issue. -- PFC FDA Task Force

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