Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment

Some of the common side effects of the injectable gonadotropins, used during fertility treatments, are pain at the injection site, skin erythema, muscle pain, and rarely vasovagal reflex. These side effects cause inconvenience and lower patient's tolerance for fertility treatments.The purpose of this study was to evaluate the safety and efficacy of an FDA-approved dose of nasal human menopausal gonadotropins (Menopur) in women undergoing fertility treatment. Healthy regularly cycling reproductive-aged women (n=4) with infertility were enrolled. A total of 75 IU of each Menopur bottle was dissolved and placed in a nasal pump spray device (concentration of 3.75 IU/spray). Each participant was allowed to inhale a total of 2 sprays daily after which ovarian response during the follicular phase was monitored by transvaginal ultrasound and serum hormone measurement. None of the participants reported any side effects at the nasal site of drug administration. No known common side effects of the Menopur drug were reported by any of the participants. Despite adequate absorption of the nasal Menopur, as confirmed by elevated serum FSH levels while taking the nasal medication, 3 out of 4 participants did not show any follicular growth until cycle day 13 while only one participant who agreed to continue taking the medication until cycle day 20 developed one dominant follicle and had elevated serum estradiol levels. This FDA approved case series suggest that nasal route of Menopur administration seems to be safe at a very low doses and it constitutes a potential novel approach for ovarian stimulation.