Clinical Comparative Study of GyneFix IN and ML Cu375 Intrauterine Devices

The objective of this study was to observe the effectiveness and side effects of the GyneFix IN intrauterine device (IUD) in clinical use. The present study is a randomized clinical control trial [in which] 1956 healthy parous women were randomly allocated into the GyneFix IN group (n = 980) and the ML copper (Cu) 375 group (n = 976). Follow-up was arranged at 1 3 6 and 12 months after insertion. The discontinuation rates were calculated by using the life table method. At the end of the first year the pregnancy rate with IUDs and expulsion rate were 0.4% and 2.3% in the GyneFix IN group. It was the same as in ML Cu375 group (0.4% 2% P > 0.05). The removal rate for medical reasons and the use-related discontinuation rate were 0.4% and 3.1% respectively in GyneFix IN group which were significantly lower than that in ML Cu375 group (1.5% 4.2% P < 0.01). GyneFix IN IUD has high effectiveness low expulsion rate and can significantly reduce the occurrence of side effects of bleeding and pain. (authors)