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Lugano, Switzerland

Baker V.L.,Stanford University | Jones C.E.,Institute Biochimique SA IBSA | Cometti B.,Institute Biochimique SA IBSA | Hoehler F.,Biostatistician Consultant | And 4 more authors.
Fertility and Sterility | Year: 2010

Objective: To compare a US clinical trial of gonadotropin therapy for IVF with a similar European trial to determine what factors may explain the higher clinical pregnancy rate in the US trial. Design: Comparison of baseline, treatment, and outcome variables in the United States (US) and European trials. Setting: IVF practices in the US (n=4) and Europe (n=6). Patient(s): 297 women undergoing IVF. Intervention(s): None. Main Outcome Measure(s): Clinical pregnancy rate. Result(s): Clinical pregnancy rates were 43.4% in the US compared with 29.7% in Europe (p=0.016), with a live birth rate of 38.2% versus 27.6% (p=0.064). This difference in clinical pregnancy rate could not be explained by differences in the US versus Europe for number of embryos transferred (2.3 vs. 2.6) or female age (34.6 vs. 30.4). Although the starting dose of gonadotropin was higher in the US trial compared with the European trial (300 versus 225 IU), the total dose of gonadotropin was only slightly higher in the US. In multiple logistic regression analysis of 81 pretransfer variables on clinical pregnancy, the only two found to be significant predictors of outcome were baseline endometrial thickness following down-regulation and number of days of gonadotropin treatment. Conclusion(s): This study suggests the possibility that US pregnancy rates may be higher in part because of differences in down-regulation or gonadotropin dosing. Other factors not assessed in these studies or in national datasets likely also contribute to the difference in pregnancy rates. Copyright © 2010 American Society for Reproductive Medicine, Published by Elsevier Inc.

Bernareggi A.,Institute Biochimique SA IBSA | Grata E.,Alpine Institute for Chemistry and Toxicology | Pinorini M.T.,Alpine Institute for Chemistry and Toxicology | Conti A.,Alpine Institute for Chemistry and Toxicology
Pharmaceutics | Year: 2013

Patients on treatment with levothyroxine (T4) are informed to take this drug in the morning, at least 30 min before having breakfast. A significant decrease of T4 absorption was reported, in fact, when T4 solid formulations are taken with food or coffee. According to preliminary clinical study reports, administration of T4 oral solution appears to be less sensitive to the effect of breakfast beverages on oral bioavailability. In the present study, stability of T4 oral solution added to breakfast beverages was investigated. A 1 mL ampoule of single-dose Tirosint® oral solution (IBSA Farmaceutici Italia, Lodi, Italy) was poured into defined volumes of milk, tea, coffee, and coffee with milk warmed at 50 °C, as well as in orange juice at room temperature. Samples were sequentially collected up to 20 min and analyzed by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. The results of the study demonstrated that T4 is stable in all beverages after 20 min incubation. Demonstration of T4 stability is a prerequisite for a thorough evaluation of the effect of breakfast beverages on the bioavailability of T4 given as oral solution and for a better understanding of the reasons underlying a decreased T4 bioavailability administered as solid formulations. © 2013 by the authors; licensee MDPI, Basel, Switzerland.

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