为了观察新型立体式网状宫内节育器（3-DR-IUD）的避孕效果及副反应，将152 例志愿受试者随机分为两组，即接受3-DR-IUD组和放置元宫药铜宫内节育器(2-D-IUD)组，每组各76 例，常规放置3-DR-IUD和2-D-IUD。分别于术后1 个月、3 个月、6 个月和12 个月进行随访，了解放置宫内节育器（IUD）后副反应（如腹痛、腰痛、阴道出血持续时间及出血量、白带等）的发生率、带器妊娠率、IUD脱落率、因症取出率、续用率及避孕效果，并利用B超、X光腹部平片检查3-DR-IUD位置等。两组各76 例均成功放置了IUD，术中均无明显疼痛。3-DR-IUD组术后出现白带增多、月经期延长、不规则出血、月经量增多及腰腹部疼痛等副反应6例(7.9%)，而2-D-IUD组出现31例（40.8%），两组比较差异有统计学意义(P<0.000 1)。3-DR-IUD 组无脱落，无带器妊娠者，3 个月时因对硅橡胶过敏取出1 例，12 个月时终止率为1.3 %，续用率为98.7 %（75/76）；2-DIUD组终止率为13.2 %，续用率为86.8 %（66/76），两组比较差异有统计学意义(P=0.009)。实验结果表明，3-DR-IUD具有很好的避孕效果，术后副反应轻微，可为育龄妇女提供新的、安全、高效的IUD。

This study aimed at exploring a new 3-dimensional reticular intrauterine device (3-DR-IUD) composed of nitinol and silicone rubber and observing the contraceptive efficacy and side effects of the device in reproductive women. The frame of the 3-DR-IUD was constructed with silicone rubber and nitinol wire. The 3-DR-IUD was placed into uterus in an outpatient procedure. One hundred and fifty- two women were divided equally into the 3-DR-IUD group (n=76) and the 2- dimensional intrauterine device (2- D- IUD) group (n=76，control group). Patient follow-ups were performed in 1～12 months post-operation. The side effects of intrauterine device (IUD)，such as abnormal leucorrhea，menstrual flow changes in uterine bleeding profusely and pain，etc，were investigated. The pregnancy rate，expulsion rate，removal rate of IUD for medical reasons and the continuation rate were evaluated. The ultrasound and pelvic X-ray were carried out to examine IUDs. The results showed that two groups with 76 cases of each successfully placed IUD and there were no severe pain during the operation. The incidence of lumbago/abdominal pain and the occurrence of leucorrhea and irregular vaginal bleeding in the 3-DR-IUD group (7.9 %，6/76) were significantly lower than that of the 2-DIUD group (40.8 %，31/76) during the first 12 months for use of IUD (P<0.000 1). The pregnancy rate，expulsion rate and take-off rate due to symptom were 0 %，0 % and 1.3 % in 3-DRIUD group，respectively，and 1 of 76 woman take-off 3-DR-IUD was due to allergy for silicon rubber. The continuation rate was 98.7 % (75/76) in the 3-DR-IUD group，comparing with the 2-D-IUD group (86.8 % ，66/76)，the difference was significantly (P=0.009). Therefore，the 3-DR-IUD demonstrates long-term patient tolerability，satisfaction and efficacy as a contraceptive.The 3-DR-IUD appears to be a new，safe and effective devise of contraception.