Three-year efficacy and acceptability of the GyneFix 200 intrauterine system

OBJECTIVE: This study was conducted to evaluate the efficacy of a "mini" version of the frameless intrauterine system (IUS; GyneFix), which has a copper surface area of approximately 200 mm(2). The small GyneFix version consists of four copper cylinders instead of six and is only 2 cm long. MATERIALS AND METHODS: A total of 392 insertions were performed in an open nonrandomized study in parous (76%) and nulligravid/nulliparous (24%) women in Belgium and China. This interim analysis reports on 13,699 women-months of use. All women were followed-up for a minimum of 12 months, up to 3 years and longer. RESULTS: Four pregnancies occurred with the GyneFix 200 IUS in this study, of which one occurred after unnoticed expulsion of the device, yielding a cumulative failure rate of 0.48 at 3 years. The cumulative removal rate for medical reasons was 1.65 at 3 years and the expulsion rate was 0.39. These low event rates resulted in a high continuation of use (93.92 at 3 years). Neither perforations nor pelvic inflammatory disease cases were encountered in this study. CONCLUSION: The present study suggests that the GyneFix 200 IUS is highly effective and probably as effective as the standard GyneFix IUS. This is attributed to the anchoring of the device to the fundus of the uterus, promoting its contraceptive action. The total surface area of the device, releasing a maximum amount of copper ions, is the fundamental difference between it and conventional IUDs and is probably essential in obtaining the high contraceptive efficacy seen in this study. The small total surface area of the GyneFix 200 IUS also minimizes menstrual bleeding and is an improvement over larger types of conventional IUDs, as indicated by the low removal rate for abnormal bleeding with the small GyneFix.     

The 'frameless' intrauterine system for long-term,reversible contraception: a review of 15 years of clinical experience

AIM: The development of the 'frameless' intrauterine system (IUS) is a response to the growing need to develop high-performing, long-acting, reversible, and acceptable contraceptives with a high continuation of use. METHODS: This is a review of 15 years of clinical experience in randomized controlled and non-randomized clinical trials. RESULTS: The IUS has a similar failure rate as the TCu380A Intrauterine device (IUD), considered the 'golden standard' IUD, which is attributed to the optimal target delivery of the copper ions in the upper part of the uterine cavity. Its performance is further optimized by the atraumatic design, which reduces partial and total expulsion and minimizes the side-effects and discomforts experienced with conventional 'framed' IUDs. The mini IUS is likely to further reduce the menstrual blood loss due to the very small size. The safety of the anchoring concept is beyond doubt as was demonstrated in all clinical studies covering 15,000 woman-years experience. CONCLUSIONS: Young nulliparous/nulligravid and parous women may significantly benefit from the advantages the 'frameless' IUS, which could be strategically important to help in reducing the increasing number of unintended pregnancies and induced abortions worldwide. Furthermore, the 'frameless' IUS has been shown to be highly effective for emergency contraception and for immediate postabortal insertion. The long lifespan of the IUS could constitute a cost-effective reversible alternative to irreversible female sterilization.     

GyneFix IN与活性γ型宫内节育器临床应用的对比分析

目的:对比观察新型GyneFix IN与活性γ型宫内节育器(IUD)的避孕效果及副反应。方法:以自愿选择为原则,对210例放置GyneFix IN和230例放置活性γ型IUD的妇女进行12个月的临床效果观察。结果:使用12个月时GyneFix IN和活性γ型IUD的有效续用率分别为97.14%和97.39%,人流术后放置的有效续用率更高,分别为97.06%和98.33%,两组比较均无显著性差异(P均>0.05)。在副反应方面,GyneFix IN组的点滴出血发生率为8.57%,较活性γ型组的2.17%有显著性差异(P<0.05),而活性γ型组的腰腹痛发生率为5.21%,较GyneFix IN组的1.00%,有显著性差异(P<0.05)。结论:GyneFix IN和活性γ型I UD均有理想的避孕效果,人流术后即时放置亦都安全有效,但在副反应方面各有其特点。孕龄妇女可在知情自愿的基础上,根据自身需要做出合理的选择。     

育龄妇女放置GyneFix IUD 540例的临床观察

目的观察育龄妇女放置吉妮宫内节育环（GyneFix IUD）的临床效果与不良反应情况。方法选取2008年5月至2011年5月自愿放置GyneFix IUD的已婚育龄妇女540例与2008年5月前放置母体乐IUD的218例已婚育龄妇女进行比较,观察临床使用24个月的脱落率、妊娠率、因症取出率及续用率。结果置器后24个月,吉妮组脱落率（0．19％）低于母体乐组（6．42％）,差异均有统计学意义（X^2=2．314,P〈0．05）;吉妮组续用率（98．70％）高于母体乐组（89．91％）,差异均有统计学意义（X^2=4．548,P〈0．05）;两组因症取出、带器妊娠差异均无统计学意义（X^2=1．109,P〉0．05）。结论吉妮系列IUD是避孕效果较理想的避孕措施,值得推广。     

不同时期放置吉妮致美宫内节育器的临床观察

目的：探讨不同时期放置吉妮致美宫内节育器的临床效果观察,扩大宫内节育器放置范围,提供安全的避孕方法。方法：人工流产术后自愿要求放置吉妮致美宫内节育器的育龄妇女300例为观察组,300例为对照组,于月经干净后2～3d放置吉妮致美宫内节育器。定期随访观察两组术后宫内节育器的放置情况（1、3、6、12个月）,观察避孕效果及不良反应。结果：观察组300例,失访5例,终止使用3例,其中1例是带器妊娠,2例是宫内节育器脱落,无不良反应取出。对照组300例,失访7例,终止使用1例,1例是宫内节育器脱落。结论：不同时期放置吉妮致关宫内节育器均安全、可靠、成功率高,尤其适宜使用其他类型宫内节育器失败者,也适用于宫腔大者,而且术后不良反应明显降低,值得临床推广使用。