Two years of intrauterine contraception with levonorgestrel and with copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices

IUDs releasing 20 mcg/day of levonorgestrel (LNg20) were in randomized trial together with the Copper T, model TCu 380Ag, in seven centers involving 2244 women. Two-year (25 months) gross cumulative pregnancy rates were 0.2 +/- 0.2 and 0.9 +/- 0.3 for the levonorgestrel and copper releasing devices, respectively (P greater than 0.05). There were no ectopic pregnancies in more than 1600 woman-years of use of each device. Removal rates for bleeding and/or pain or for medical reasons other than menstrual problems did not differ significantly between devices. Oligomenorrhea or amenorrhea prompted 10.7 per hundred (gross rate, 8.4 net rate) women using the LNg 20 IUD to request removal in the two-year period, significantly above the 0.2 per hundred rate among women with the Copper IUD (P less than 0.001). At the end of two years an estimated 59.4 per 100 women were continuing use of the LNg 20 IUD, and 67.5 per 100 (P less than 0.001) with the TCu 380Ag. This difference is almost wholly ascribable to a marked reduction in bleeding episodes and days among women using the LNg 20 device with concomitant removal of device. Hemoglobin rose an average of 0.5 g/dl (P less than 0.001) for this group whereas women using the TCu 380Ag experienced a decline of 0.2 g/dl compared with baseline values (P less than 0.001).     

Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD.Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.     

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.     

Intrauterine contraception with copper and with levonorgestrel: a randomized study of the TCu 380Ag and levonorgestrel 20 mcg/day devices

First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.     

The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial

Background

Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared.

Study Design

Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years.

Results

Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4-6.4) per 100 and 2.5 (95% CI: 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9-2.0) and 0.5 (95% CI: 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7-1.9) and 2.5 (95% CI: 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different.

Conclusions

The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.     

Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C

Few data on the long-term efficacy of intrauterine devies (IUD) are available, and this article reports on the final 12-year experience with the TCu220C and TCu380A devices from two randomized, multicenter trials conducted in 24 centers. A total of 3,277 and 1,396 women, respectively, were recruited for use of each device between 1981 and 1986 and followed at 3, 6, and 12 months after insertion and yearly thereafter. At the end of 12 years, a total of 17,098 women-years of experience had been accumulated for the TCu220C and 7,159 women-years for the TCu380A. The cumulative 12-year intrauterine pregnancy rates were 7.0 (standard error [SE] 0.6) per 100 women for the TCu220C and 1.9 (SE 0.5) for the TCu380A (p < 0.001). Pregnancy rates were highest in the first years after insertion; the TCu220C had a consistently higher annual pregnancy rate than did the TCu380A at all intervals since insertion. No pregnancies were reported with the TCu380A after 8 years of use. Total medical removals were approximately 6% in the first year and dropped to approximately 4% per year for each device for up to 12 years of use (cumulative 12 year rates were 37.3 [SE 1.3] and 40.2 [SE 2.1] per 100 women for the TCu220C and TCu380A devices, respectively). The overall continuation rate at all intervals since insertion was higher with the TCu220C device, mainly due to higher removal rates for nonmedical reasons with the TCu380A. The cumulative ectopic pregnancy rates were 0.7 and 0.4 for the TCu220C and TCu380A, respectively. Pregnancy rates were higher in the Chinese compared with the non-Chinese centers for both devices, though the greater efficacy of the TCu380A was apparent in both groups of centers. The total medical and nonmedical removal rates were lower in the Chinese compared with the non-Chinese centers, and did not show any substantial differences between the devices. We conclude that both devices are safe and effective for at least 12 years of use and the low pregnancy rate with the TCu380A is comparable with that reported in the United States among women who had undergone tubal sterilization. The very high efficacy of the TCu380A makes it the IUD of choice, and it can be considered as a potentially reversible, nonsurgical alternative to sterilization for women requiring very long-term pregnancy protection.     

月经间期放置MYCu宫内节育器临床效果的比较性研究

目的:了解第三代爱母宫内节育器(MYCu IUD)在月经间期放置的临床效果、副作用及对生活质量的影响。方法:对要求放置IUD避孕的育龄妇女,在月经间期随机放置MYCu IUD(MYCu组,368例)与TCu 380AIUD(TCu380A组,369例),放置后1、3、6、12个月随访观察,记录使用情况。结果:置器后12个月MYCu组与TCu 380A组随访率分别为99.45%、100.00%;置器12个月累积续用率分别为每百妇女年94.02、91.87(P0.05);带器妊娠率分别为每百妇女年0.56、0.00(P=0.1703);脱落率分别为每百妇女年0.57、1.95(P=0.0947);无因IUD下移而停用者;因症终止率分别为每百妇女年3.01、6.03(P=0.0849)。置器后1、3、6个月副作用发生率MYCu组明显低于TCu380A组(P0.05)。两组对象相关生活质量均得到改善。结论:放置MYCu IUD较TCu 380AIUD疼痛和出血的副作用少,续用率、避孕效果与TCu 380AIUD相当,是一种临床效果好、副作用发生率较低的新型IUD。     

Effectiveness of IUDs: a review

Large, multicenter, randomized trials of IUDs conducted between 1970 and 1986 encompass more than 50,000 woman-years of experience in the two-year interval following device insertion. Taken singly and collectively, these trials demonstrate that IUD failure rates are strongly affected by the age of participants, notably by the proportion of women under age 25 admitted to the studies. Individual trials and overall comparisons indicate further that: 1. Non-medicated devices such as the Mahua steel ring and Lippes loop D have pregnancy rates above 2 per 100 woman-years. 2. The first approved copper IUDs, the Copper 7 and the TCu 200, do not markedly differ in pregnancy rates from standard plastic devices with rates significantly above 2 per 100 woman-years. 3. Five more recent, widely used copper IUDs have had failure rates significantly below 2 per 100 woman-years in multicenter trials. The point estimate of the failure rate was less than 1 pregnancy per 100 woman-years for three of these IUDs. One copper-bearing device had a failure rate significantly below 1 per 100 woman-years. 4. Devices releasing either 25 mcg/day of progesterone or 2 mcg/day of levonorgestrel have had significantly higher failure rates than the more effective copper-releasing IUDs; however, devices releasing 20 mcg/day of levonorgestrel appear at least as effective as the most effective copper IUDs. Long-term IUD failure rates derived from straight assignment as well as randomized trials indicate 4-year gross cumulative failure rates do not exceed 10 per 100 for any of the standard copper devices or the Lippes loop D. Point estimates of the four-year gross cumulative pregnancy rates have been below 5 per 100 users in studies of the TCu 220C, the Nova T, the TCu 380A, and the MLCu 375.     

4种新型宫内节育器使用5年临床效果评价

为较好掌握新型 IUD 的优点和特征,便于医务人员根据不同育龄妇女身体状况选择适当的 IUD 类型,本课题对2400例育龄妇女随机放置 TCu380A、三球头 TCu220C、MLCu375SL 和含药宫铜4种新型 IUD 使用5年间的终止原因进行临床多中心研究分析。结果表明:第二代活性 IUD具有安全、高效、长效的优点,其中尤以 TCu380A 具有较高续用率(78.1/100妇女),其妊娠率(带器妊娠及意外妊娠)为4.9/100妇女,脱落率也最低,为6.9/100妇女(P<0.05);MLCu375SL 城市组使用效果明显优于农村组,其5年续用率分别为80.54/100妇女和66.89/100妇女(P<0.05);农村组脱落率最高,为14.6/100妇女(P<0.05);含药宫铜 IUD 置器后月经量增加的症状明显减少,因症取出率最低,5年末为3.7/100妇女(P<0.01);;三球头 TCu220C 具有低因症取出率和低脱落率的优点,但带器妊娠率最高,为8.4/100妇女(P<0.01)。结果提示:T 铜 IUD 的脱落率相对较低;三球头 TCu220C 的球头和含药宫铜 IUD 所含的消炎痛在减少副反应方面有一定的作用;ML-Cu375SL 适合城市妇女使用。     

MCuⅡIUD与TCu380A IUD放置60个月临床效果对比研究

目的:观察放置MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床效果及安全性。方法:国内多中心统一标准,选择2000例要求放置IUD避孕的妇女,随机放置MCuⅡIUD与TCu380A IUD各1000例,定期随访观察60个月。结果:放置满60个月,MCuⅡIUD与380ATCu IUD的带器妊娠率分别为1.83/百妇女年、2.10/百妇女年,差异无统计学意义(P>0.05);脱落率分别为0.72/百妇女年、3.03/百妇女年,差异有统计学意义(P<0.05);因出血/疼痛取出分别为4.54/百妇女年、6.12/百妇女年,副作用发生率分别为3.50%、3.80%,差异均无统计学意义(P>0.05);计划妊娠取器后两组妊娠率分别为86.6%、91.7%,差异无统计学意义(P>0.05)。结论:MCuⅡIUD避孕效应高,脱落率低,放置后出现副作用发生率低,可逆性好,是比较理想的IUD。     

Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS.

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.     

Five years' experience with levonorgestrel-releasing IUDs

Two levonorgestrel-releasing IUDs and a copper-releasing IUD of the same shape were studied in a randomized comparative study over five years. The levonorgestrel-releasing IUDs released 20 micrograms or 30 micrograms per day. The Pearl index during the 10,600 woman-months of LNG-IUD use was 0.11. The control device releasing copper had a Pearl index of 1.6. The amount and duration of menstrual bleeding was greatly reduced, leading to a high incidence of oligo- or amenorrhea. The continuation rate in this pioneer trial was 53 per 100 users for the levonorgestrel-releasing IUD (LNG-IUDs) and 50 per 100 users for the copper-releasing IUD (Nova T). The removal rates for reasons other than amenorrhea were not significantly different. Discontinuation because of amenorrhea occurred during the first two years, the cumulative termination rate for this reason was 11.6 per 100 users at five years. The LNG-IUDs removed for investigation after five years of use revealed that the devices contained about 40 percent of the original load. The effective lifespan of the device has been demonstrated by this study to be five years; the residual steroid gives an additional safety period of two more years. The LNG-IUD is a highly effective reversible contraceptive method, which strongly reduced the amount and duration of bleeding. During the first two months there is scanty but frequent spotting which, like the high incidence of oligo- and/or amenorrhea, requires counselling of health personnel and women using LNG-IUDs.     

Comparative clinical experience with 3 IUDs,TCu 380 Ag,TCu 220C and mahua ring,in Tianjin,People's Republic of China

A comparative study of three IUD models assigned at random was carried out at 5 hospitals in Tianjin. The experience of 2762 acceptors was analyzed by life table techniques. At the end of one year the net cumulative first segment pregnancy rates of the TCu 380Ag and the TCu 220C were 0.1 and 0.3 per 100, respectively, significantly below the 3.0 per 100 pregnancy rate of the Mahua double ring. The explusion rate of the TCu 220C at the end of the first year, 1.6 per 100, was significantly lower than the expulsion rates of the other two devices. Removals for bleeding and pain cumulated to 3.3 per 100 at one year for users of the TCu 220C, significantly less than 6.8 per 100 for acceptors of the TCu 380Ag. Over all categories of termination, women who used the TCu 220C had the lowest one year termination rate, 5.5 per 100, while those who were assigned the Mahua device had the highest one year termination rate, 13.9 per 100.     

四种宫内节育器的对比研究

本研究用实验流行病学方法,按随机分配原则对比了TCu380A、TCu220三球头、MLCu375SL、含药宫铜IUD四种宫内节育器(以下简称IUD)在江苏省育龄妇女中的使用效果。从1991年10月至1992年3月随机放置四种IUD,其中:TCu380A 593例,TCu220三球头606例,MLCu375SL 600例,含药宫铜IUD601例,共计2400例,农村、城市受试对象各为1200例。置器24个月时四种IUD累积续用率分别为:TCu380A 87.34/百妇女年,TCu220三球头88.41/百妇女年,MLCu375SL 87.32/百妇女年,含药宫铜型88.18/百妇女年,组间比较无显著差异(P>0.05);因妊娠、脱落、出血/疼痛终止率,四种IUD间均无显著差异;含药宫铜IUD明显降低出血副反应的发生率;按城、乡分组在24个月时农村组续用率较高,对此结果进行了探讨。     

The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women

The objective of this paper was to compare the efficacy, acceptability, safety, and bleeding patterns of TCu 380A intrauterine device (IUD) and progesterone-releasing vaginal ring used by breastfeeding women. The study population included 97 breastfeeding women using IUD and 100 women using vaginal ring. Of the IUD users, no insertion failure, perforation, or accidental pregnancy occurred in 12 months. There was one IUD expulsion. There were no discontinuations of IUD due to medical reasons other than expulsion. The total discontinuation rate was 2.3%. In the ring group, no accidental pregnancy occurred. The major reasons for discontinuation were ring use-related problems and vaginal problems. The total discontinuation rate was 65.4% within 1 year. The frequency of any one complaint among the ring users was higher than that among the IUD users. There were no differences in the proportion of women having no sexual activity and in the weight of their babies between the two groups. Compared with the IUD users, the median number of bleeding/spotting (B/S) episodes and B/S days of the vaginal ring users were fewer; consequently, the mean length of B/S-free interval was longer in all four reference periods; the mean length of B/S episode and segment were the same; the occurrence of amenorrhea was more frequent; in contrast, the proportions of normal bleeding patterns were fewer. The frequencies of prolonged bleeding, frequent bleeding, and infrequent bleeding patterns did not differ between the two groups. The percentage of irregular bleeding was fewer only in the first two reference periods. It is concluded that the TCu 380A IUD and progesterone-releasing vaginal ring used by breastfeeding women are safe and effective. The higher discontinuation rate of the ring users was mainly because of use-related problems. Breastfeeding women with TCu 380A IUD had better tolerance and acceptability. The TCu 380A IUD does not, but the progesterone-releasing vaginal ring does, suppress the recovery of ovarian function. However, once return of menstruation occurred, there were no differences in bleeding patterns between the two contraceptive methods.     

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.     

B超监测下放置吉妮IN IUD的临床效果观察

目的:观察B超监测放置吉妮IN IUD宫内节育器的临床效果。方法:多中心随机分组在B超监测下放置吉妮IN IUD289例,TCu380A IUD 303例,分别于术后1、3、6、12、24、36个月行妇科及B超随访,以生命表方法统计结果并行显著性检验。结果:①术后疼痛TCu380A组明显高于吉妮IN组(P<0.05);术后6~36月,月经紊乱以TCu380A组为高(P<0.05)。②两组带器妊娠率均较低(吉妮IN组1.04/100妇女,TCu380A组1.32/100妇女,P>0.05);脱落率TCu380A组(6.60/100妇女)高于吉妮IN组(4.84/100妇女,P<0.05);吉妮IN组因出血和疼痛的终止率(2.77/100妇女)较TCu380A组(5.61/100妇女)低(P<0.05)。结论:吉妮INIUD具有与TCu380A IUD同样高的避孕效率,其在降低脱落率、因症取出率及副反应发生率方面优于TCu380A IUD。     

Postplacental placement of intrauterine devices: A randomized clinical trial

ObjectiveTo compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52 mg intrauterine system (IUS) up to 90 days after postplacental placement (10 min after delivery of the placenta).Study designRandomized trial (1:1) of women aged 18–43 years and ≥37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion.ResultsWe enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08–15.10; P < 0.00) and higher among women with one (OR 4.38; 95% CI 1.33–14.43; P 0.00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78–20.77; P 0.00) than those with two deliveries.ConclusionsPostplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days.ImplicationsPolicy makers should increase the availability of both the TCu380A and the LNG intrauterine devices for the immediate postpartum period, even though the expulsion rate is higher than that after interval placement.     

A comparative randomized study of three different IUDs in nulliparous Mexican women

With the aim to evaluate the clinical performance of intrauterine devices (IUDs) especially designed for nulliparous women (TCu 380 Nul and ML Cu 375 sl), a prospective randomized, single-blind study comparing them with standard TCu 380 A, was carried out. We included 1170 healthy nulliparous women randomly allocated to receive any of the three types of IUDs and conducted follow-up for 1 year of use. Continuation and termination rates were evaluated by gross cumulative life table analysis and compared by the log-rank test. Continuation rates (95% confidence interval) at the end of the study for TCu 380 A, TCu 380 Nul and ML Cu 375 sl were 29.5% (+/-12.9), 85.9% (+/-5.3) and 85.4% (+/-5.8), respectively (p < 0.001). There were six pregnancies during the first 3 months of use, for a failure rate of 1% (+/-0.6) in the TCu 380 A group, 0.5% (+/-0.3) in TCu 380 Nul, and no pregnancy in ML Cu 375 sl (p < 0.05). Especially designed IUDs for nulliparous women had a better clinical profile compared with the standard IUD. This may improve the use of IUD in this population.     

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.