Genetic evaluation of oocyte donors: recipient couple preferences and outcome of testing.

OBJECTIVE: To report preferences of recipient couples for genetic testing of their oocyte donors. DESIGN: Observational report of results from a genetic testing-options form implemented as part of routine care. SETTING: Private practice. PATIENT(S): Recipients and oocyte donors. INTERVENTION(S): Recipient couples completed a form before screening of their oocyte donor that outlined required screening and recommended tests that the couple could accept or decline. Couples were given information about carrier frequency, risk to their child if results were abnormal, and cost. MAIN OUTCOME MEASURE(S): Percentage of couples accepting optional testing. RESULT(S): Of the 63 couples with data available from their first testing-options form, 42 (67%) accepted and 21 (33%) declined fragile X testing, whereas 34 (54%) accepted and 29 (46%) declined karyotyping. When asked whether they would accept additional testing of their donor if it was recommended by a genetic counselor, 15 (24%) said that they would accept additional testing regardless of cost, 35 (56%) declined, and 13 (20%) indicated that their decision would depend on the cost. In many cases, history was elicited by the genetic counselor or test results were obtained that influenced further testing, decisions to proceed, or provided information important for the child. CONCLUSION(S): Recipient couples sometimes chose to decline tests that we recommended but did not require, despite the relatively low cost of this testing compared with the total cost of the oocyte donation cycle.

Economic cost for implementation of the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 in an egg donor program.

OBJECTIVE: To assess the economic cost of implementing the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 for infectious screening of egg donors in our practice during the first year. DESIGN: Physicians and employees of our practice were surveyed to ascertain the scope of duties and the number of hours spent to implement the regulations. The economic cost to the practice and the cost of additional laboratories were calculated. SETTING: Private practice. PATIENT(S): Egg donors and recipient couples who underwent treatment in our center from May 25, 2005 (the day regulations became effective) to May 25, 2006; and physicians, administrators, and staff who were employed by the practice during this time frame. INTERVENTION(S): Using a questionnaire, structured interviews were conducted for all physicians and employees of our practice. The information regarding number of hours was provided to our chief financial officer, who calculated the cost to the practice. The cost that recipient couples paid for laboratory tests that would not otherwise be required to meet American Society for Reproductive Medicine guidelines and the cost of an external audit were also added to the overall practice costs to determine a total cost associated with the regulations in the first year. MAIN OUTCOME MEASURE(S): List of activities associated with implementation of the regulations, personnel hours involved to implement the regulations, and economic cost to the practice and to recipient couples. RESULT(S): The total number of personnel hours spent by our practice in preparation for implementation of the regulations was 623.3 hours. In the first year, 675.2 additional hours were required to implement the regulations for 40 donors who cycled during this time. The economic cost to the practice for both preparation and implementation of the regulations was $219, 838, and the cost of additional laboratory work borne by the recipient couples was $15,880. Thus, the total cost was calculated to be $235,718 at 1 year after implementation of the regulations. CONCLUSION(S): Implementation of the FDA 21 CFR, Part 1271 was associated with a very high economic cost, even if the costs incurred by the government to develop and implement the regulation are excluded.

Correlation of thyroid stimulating hormone (TSH) level with pregnancy outcome in women undergoing in vitro fertilization.

OBJECTIVE: The aim of this study was to determine if pregnancy outcome for women undergoing in vitro fertilization is correlated with pre-conception thyroid-stimulating hormone level. STUDY DESIGN: We performed a retrospective cohort study of in vitro fertilization cycles in our private practice with an initial positive serum human chorionic gonadotropin level and thyroid-stimulating hormone level available (n = 364). We examined whether or not birth outcome differed between cycles in which the thyroid-stimulating hormone was > 2.5 mIU/L compared with cycles with a thyroid-stimulating hormone level of < or = 2.5 mIU/L. Logistic regression was used to determine the association between thyroid-stimulating hormone level and spontaneous abortion rate. RESULTS: Delivery outcome was available for 195 cycles, 36% of which had a thyroid-stimulating hormone level > 2.5. The gestational age at delivery was higher in cycles with a thyroid-stimulating hormone < or = 2.5 than for cycles with a thyroid-stimulating hormone > 2.5 (38.5 vs 38.0 weeks for singletons, 36.0 vs 34.6 weeks for twins, overall P = .012 for thyroid-stimulating hormone level). The mean birth weight for cycles with a thyroid-stimulating hormone < or = 2.5 was higher than for cycles with a thyroid-stimulating hormone > 2.5 (7.33 vs 6.78 lbs for singletons, P = .024 and 5.36 vs 4.83 lbs for twins, P = .023). Restricting analysis to cycles where the woman was not taking thyroid replacement did not change the overall conclusions. There was a trend toward increasing risk of miscarriage with increasing thyroid-stimulating hormone level in nondonor cycles, controlling for age and day 3 follicle-stimulating hormone level, but this trend did not reach statistical significance. CONCLUSION: A pre-conception thyroid-stimulating hormone level > 2.5 mIU/L is associated with a lower gestational age at delivery and lower birth weight in women undergoing in vitro fertilization.