Previous studies have suggested an association between a variant in the promoter region of the FSHR gene and diminished response to controlled ovarian hyperstimulation (COH) in women undergoing assisted reproduction. FSHR -29G>A was genotyped in 559 women undergoing their first cycle of COH for IVF/intracytoplasmic sperm injection (ICSI) using TaqMan allelic discrimination assay. Correlation and regression analysis was performed to assess the relationship between FSHR promoter genotypes and markers of ovarian reserve and measures of response to COH, including the number of oocytes retrieved, gonadotrophin dose used and the live-birth rate. There were no statistically significant differences between the genotype frequencies and the markers of ovarian reserve or the early measures of response to COH. However, the live-birth rate was higher for women carrying the variant A allele (odds ratio [OR] 1.37; 95% confidence interval [CI] 1.02-1.84 per allele). This relationship did not reach statistical significance after adjustment for the number of embryos transferred (OR 1.33; 95% CI 0.98-1.83 per allele). Results from this study do not provide evidence that the FSHR -29G>A variant can be used in the individualization of the treatment protocol for women undergoing IVF/ICSI.
OBJECTIVE: This study compared handling errors and preference ratings before and after use of four currently available r-hFSH pen injectors tested by women with infertility and fertility nurses.DESIGN: This was a simulated use study comparing the GONAL-f Ò (Merck KGaA, Germany), Bemfola Ò (Gedeon Richter PLC, Hungary), Rekovelle Ò (Ferring Pharmaceuticals Ltd, UK) and Ovaleap Ò (Teva BV, The Netherlands) pen injectors in Germany, Poland and the UK.MATERIALS AND METHODS: Injector-na€ ıve women with infertility and injector-experienced fertility nurses tested pen injectors with masked labels in a randomized testing order. Simulated injections were made into a foam pad following the instructions for use (IFU) and injectors were rated before and after use. Handling errors were noted by the moderator during the study. After the study, errors were grouped according to severity and use-steps indicated in the IFU. Ordinal or Poisson linear mixed models were applied, adjusted for injector and testing order with an unstructured correlation matrix between measures (or with non-convergence, non-parametric or normal approximation to the Poisson methods). All analyses were exploratory by nature without any correction for multiplicity.RESULTS: A total of 120 women with infertility and 60 fertility nurses participated. All participants tested GONAL-f and Bemfola injectors. Because of their similarity, participants tested either Rekovelle (71 women; 30 nurses) or Ovaleap (49 women; 30 nurses) injectors. Before simulated use, mean ratings from women with infertility were similar between the GONALf and other pen injectors. After use, the ratings from women were higher for GONAL-f vs other pen injectors (p<0.001 for all comparisons). Fertility nurses rated the GONAL-f injector higher than the other pen injectors both before and after simulated use, with the difference in ratings larger after simulated use (p<0.01 for all comparisons vs GONAL-f). Adjusted rates of total handling errors for both women with infertility and fertility nurses were lower with the GONAL-f pen injector (p<0.001 for all comparisons vs GONAL-f). Adjusted rates of total handling errors (95% CI) for women with infertility were 1.
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