ObjectiveThe purpose of this paper is to review the experience with the frameless, anchored, GyneFix copper-releasing intrauterine contraceptive devices (IUCDs/IUDs) (Contrel Europe, Belgium), and to demonstrate their high acceptability and low rate of discontinuation of use, which could contribute to current efforts that aim to reduce radically the high number of unintended pregnancies and induced abortions, particularly in young women.Materials and methodsThis paper is based on studies that examined the differences in uterine volume and cavity size, related to age and parity, and on original clinical research data and practical experience with frameless copper IUDs, as well as on literature data on the IUD–endometrial cavity relationship of conventional IUDs, with special reference to side effects and user discontinuation.ResultsThe mean transverse diameter in nulliparous and parous women is significantly less than the length of the transverse arm of the TCu380A IUD (ParaGard, Duramed, NY, USA) or the levonorgestrel intrauterine system (Mirena, Bayer, Germany). Small, frameless, flexible, and unidimensional copper IUDs appear to be well tolerated, with less impact on menstrual bleeding, resulting in low discontinuation rates when compared with standard-size conventional IUDs, which often result in increased expulsion rates, complaints of pain and erratic or increased menstrual bleeding, and subsequent high rates of discontinuation, particularly in young women.ConclusionThe unidimensional GyneFix IUDs fit the majority of uterine cavities. An IUD that fits is likely to result in increased tolerance and continued use of the method. As this would appeal to women, the logical result should be greater use of the method and fewer unintended pregnancies and induced abortions. Recommending the standard TCu380A (ParaGard) IUD or the Mirena levonorgestrel intrauterine system, primarily developed for use in parous women, for general use in nulliparous and adolescent women should be done with caution in the light of current scientific evidence, except if 3-D sonography indicates that the uterine cavity is sufficiently large.

The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 woman years of experience and up to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

BackgroundThe purpose of this study was to provide additional data on the experience with frameless copper and levonorgestrel (LNG) intrauterine devices (IUDs) in nulliparous and adolescent women.MethodsNulliparous and adolescent women, 25 years of age or younger, using the frameless copper IUD or the frameless LNG-releasing intrauterine system (IUS), were selected from previous studies and a current multicenter post-marketing study with the frameless copper IUD. The small copper-releasing GyneFix® 200 IUD consists of four copper cylinders, each 5 mm long and only 2.2 mm wide. The frameless FibroPlant® LNG-IUS consists of a fibrous delivery system releasing the hormone levonorgestrel (LNG-IUS). The main features of these intrauterine contraceptives are that they are frameless, flexible, and anchored to the fundus of the uterus.ResultsOne hundred and fifty-four nulliparous and adolescent women participated in the combined study. One pregnancy occurred with the GyneFix 200 IUD after unnoticed early expulsion of the device (cumulative pregnancy rate 1.1 at one year). Two further expulsions were reported, one with the GyneFix 200 IUD and the other with the FibroPlant LNG-IUS. The cumulative expulsion rate at one year was 1.1 with the copper IUD and 2.2 with the LNG-IUS. The total discontinuation rate at one year was low (3.3 and 4.3 with the copper IUD and LNG-IUS, respectively) and resulted in a high rate of continuation of use at one year (96.7 with the copper IUD and 95.7 with the LNG-IUS, respectively). Continuation rates for both frameless copper IUD and frameless LNG-IUS remained high at 3 years (>90%). There were no cases of perforations or pelvic inflammatory disease reported during or following insertion.ConclusionThis report confirms earlier studies with frameless devices and suggests that the high user continuation rate is attributable to the optimal relationship between the IUD and the uterine cavity. IUD studies have shown that an IUD that does not fit well will often lead to side effects (ie, pain, bleeding, embedment, expulsion) and subsequent removal of the IUD. Early discontinuation is not the aim of long-acting reversible contraception.

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The results obtained compare favorably with those obtained in previous studies conducted following the removal of copper IUDs. The use of the frameless IUD does not affect future fertility in nulligravid/nulliparous and parous women wishing to become pregnant following removal of the device. Nulliparous women conceive significantly earlier than parous women.