Mixed protocols: multiple ratios of FSH and LH bioactivity using highly purified, human-derived FSH (BRAVELLE) and highly purified hMG (MENOPUR) are unaltered by mixing together in the same syringe.

ABSTRACT

BACKGROUND: The use of mixed or blended protocols, that utilize both FSH and hMG, for controlled ovarian hyperstimulation is increasing in use. To reduce the number of injections a patient must administer, many physicians instruct their patients to mix their FSH and hMG together to be given as a single injection. Therefore, the goal of this study was to definitively determine if the FSH and LH bioactivities of highly purified, human-derived FSH (Bravelle) and highly purified hMG (Menopur) were altered by reconstituting in 0.9% saline and mixing in the same syringe. METHODS: Bravelle and Menopur were reconstituted in 0.9% saline and mixed in a Becton Dickinson plastic syringe. The FSH and LH bioactivities of the products were determined after injecting female and male rats, respectively, with Bravelle, Menopur, or a mixture of Bravelle and Menopur. Ratios of FSHLH activity tested were 15075 IU (1 vial Bravelle 1 vial Menopur), 30075 IU (3 vials Bravelle 1 vial Menopur) or 300225 IU (1 vial Bravelle 3 vials of Menopur). RESULTS: There were no statistically significant changes in either FSH or LH bioactivity that occurred after mixing Bravelle with Menopur in the same syringe. The theoretical vs. actual FSH bioactivity for Bravelle and Menopur were 75 vs. 76.58 IU/mL and 75 vs. 76.0 IU/mL, respectively. For the 3 ratios of FSHLH activity tested, 15075 IU (1 vial Bravelle 1 vial Menopur), 30075 IU (3 vials Bravelle 1 vial Menopur) or 300225 IU (1 vial Bravelle 3 vials of Menopur) tested, the theoretical vs. actual FSH bioactivities were 150 vs. 156.86 IU/mL, 300 vs. 308.69 IU/mL and 300 vs. 306.58 IU/mL, respectively. The theoretical vs. actual LH bioactivity for Menopur in the above mentioned ratios tested were 75 vs. 77.50 IU/mL. For the 3 ratios of FSHLH activity tested, 15075 IU (1 vial Bravelle 1 vial Menopur), 30075 IU (3 vials Bravelle 1 vial Menopur) or 300225 IU (1 vial Bravelle 3 vials of Menopur), the theoretical vs. actual LH bioactivities were 75 vs. 78.38 IU/mL, 75 vs. 78.63 IU/mL and 225 vs. 233.48 IU/mL, respectively. CONCLUSION: Mixing human-derived FSH (Bravelle) with highly purified hMG (Menopur) in the same diluent, 0.9% NaCL, does not alter the FSH or LH bioactivity of either gonadotropin preparation.