[Randomized comparative study of GyneFix IN and TCu 380A intrauterine devices].
OBJECTIVE
To observe the clinical performances of the new intrauterine device (IUD)-GyneFix IN.


METHODS
The present study is a randomized comparative clinical trial. 607 healthy parous women were randomly allocated into GyneFix IN group (n = 302) or TCu 380A group (n = 305). IUD was inserted during the menstrual interval by the trained investigators. Follow-up were arranged at 1, 3, 6 and 12 months after insertion. The discontinuation rates were calculated by life table method.


RESULTS
At the end of the first year, there was no pregnancy occurred in GyneFix IN group. Its expulsion rate and removal rate for medical reasons were 2.67 and 1.02 per 100 women respectively. The use-related discontinuation rates was 3.66, which was significantly lower than that in the TCu 380A group (7.88, P < 0.05). The number of women with complaint of pain was also less in GyneFix IN group.


CONCLUSIONS
The excellent performance of the new IUD which is a frameless device with high copper surface and anchoring system was confirmed by this multicentre trial. Due to lower expulsion rate and less side effect of pain, it could be recommended.
Wu
S
S
National Research Institute for Family Planning, Beijing.
Hu
J
J
Wu
M
M
D000293:Adolescent; D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007433:Intrauterine Device Expulsion; D007435:Intrauterine Devices, Copper