Evaluación de la efectividad, seguridad y coste-efectividad de la gonado-tropina menopáusica humana altamente purificada: Estudio de uso con Menopur® en Inseminación Artificial Intrauterina (IAC/ IAD)

The study pursued three objectives. Firstly to assess the clinical efficacy of the highly purified human menopausal gonadotrophin (hMG-HP; Menopur®) in the treatment of sterility by means of intrauterine insemination (IUI) under daily clinical practice conditions in terms of clinical pregnancy rate. Secondly the study expected to evaluate its safety and finally its cost/effectiveness. It was a phase IV study, postauthorization, prospective, opened, multicentric in the conditions of authorized use and according to the daily clinical practice. The study was carried out in 23 national centres specialist in assisted reproduction of the national territory, under daily medical practice conditions and according to the clinical practice. The study was authorized by the corresponding local and national ethical committees and lasted between 2004 and 2006. Sterile couples with indication of AIH or AID were studied. Primary outcomes analyzed are following rates and ratios: pregnancy per initiated cycle, multiple pregnancy, ovarian hyperstimulation, miscarriage, treatment cancellation rate and drug treatment cost per obtained pregnancy. Observations corresponding to 207 couples were included, they were treated with 470 cycles of insemination. The clinical pregnancy rate per cycle started was 11,0% in AIH and 28,9% in AID. The rate of multiple pregnancy was of 7,9% in AIH and 15,4% in AID. Two cases of slight SHO were reported (0,5%) and the global miscarriage rate was 7,4% (CI 95%: 0.44-15.16). Cancellation rate was 5,9% and the mean medicine cost per cycle was 1917 € in IAC and 829 € in IAD. The results obtained in the treatment with Menopur® associated with intrauterine insemination in terms of efficacy and safety can be compared with the last scientific societies registers in what refers to the treatments with different gonadotrophin preparations.