Assuring the quality of human menopausal gonadotropin (menotrophin) batches by establishing their fsh and lh activities before use in treatment of infertility

Human menopausal gonadotrophin (HMG) or menotrophin causes growth and maturation of the ovarian follicle in women who do not have primary ovarian failure by mimicking the action of endogenous LH and FSH and in men it promotes sperm formation if testosterone level and FSH levels are low. Therapeutic menotrophins are preparations of gonadotrophins having both FSH and LH activity, extracted from the urine of postmenopausal women, which have undergone additional steps for purification and then used as fertility treatment. In this study, we are reporting the evaluation of 23 batches of therapeutic menotrophin as per US pharmacopeia, for establishing their identity as well as Follicle Stimulating Hormone (FSH) activity and Lutenizing Hormone (LH) activity before batch release into the market for use in patients in India. The results were calculated by using the Parallel-line assay; COMBISTATS v 4.0 software from EDQM. Based on the findings, it was established that all the 23 batches were identified to be menotrophin and their estimated potencies of both FSH activity and LH activity were found to be within the specification limits as per the US Pharmacopeia.