Frameless Intrauterine Device Research Articles

Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12

ObjectiveTo compare the incidence of expulsion for different copper intrauterine device (IUD) shapes. Study designWe conducted a secondary analysis of the ongoing, prospective, non-interventional European Active Surveillance Study on LCS12 (EURAS-LCS12). Users of newly inserted IUDs were recruited in 10 European countries via a network of approximately 1200 clinicians. We restricted the analysis to copper IUD users. In the main analysis, we classified copper IUDs by shape [Nova-T frame, Tatum-T frame, Multiload frame, frameless IUDs and intrauterine balls], without differentiation of size. We calculated the cumulative incidence, crude, and adjusted hazard ratios for expulsion. Covariates included in the adjusted analyses were age, BMI, parity, education, income, IUD user status, marital status, length of device, heavy menstrual bleeding, and clinician’s experience. ResultsWe included 26,381 copper IUD users from the EURAS-LCS12 dataset for this study. The most frequently used IUD shape was the Nova-T frame (14,724 [55.8%]) followed by the Tatum-T frame (4276 [16.2%]), frameless IUDs (3374 [12.8%]), Multiload frame (2962 [11.2%]), and intrauterine balls (IUBs) (1045 [4.0%]). Cox regression analysis regarding expulsions yielded an adjusted hazard ratio of 0.8 (95% CI, 0.7–1.0), 1.3 (95% CI, 1.0–1.8), 1.6 (95% CI, 1.2–2.1) and 3.6 (95% CI, 2.7–4.9) for Nova-T frame IUD, frameless IUDs, Multiload frame IUDs and IUBs versus Tatum-T frame IUD, respectively. ConclusionThe risk of expulsion following placement of a copper IUD is related to IUD shape, with Nova-T frame and Tatum-T frame IUDs demonstrating the lowest risk. ImplicationsOur finding of a higher risk of expulsion observed with Multiload frame, frameless, and intrauterine ball copper IUDs compared to Tatum-T frame and Nova-T frame devices during real world use has clinical importance. Clinicians may choose to use these data when counseling patients.

TEMPORARILY WITHDRAWN: Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12

This article has been temporarily withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal

Assessment of a Novel Fixation Method of a Frameless Intrauterine Contraceptive Device Inserted during Cesarean Delivery as a Means of Preventing Displacements and Expulsions: A Prospective Observational Study.

The primary objective of this study was to assess the novel fixation method of a frameless copper-releasing intrauterine device inserted following placental delivery during cesarean section and analyze its impact in reducing device displacement and expulsion during and after uterine involution. We hypothesized that the dual-anchoring technique could reduce the risk of intrauterine device displacement and expulsion during and after the uterine involution. The study was conducted at the Gazi University Medicine Faculty Hospital in Ankara, Turkey. Twenty-one pregnant women were enrolled. Insertion was performed following placental removal. To confirm the proper placement and good retention of the device, the distance between the fundal serosa (S) and device anchor knot (A) was measured (S–A) during follow-ups, by ultrasound. There were significant differences in the S–A, as observed by ultrasound at discharge and at 6 weeks post-delivery, which is consistent with the tissue contractions associated with uterine involution. Notwithstanding the uterine involution, no device displacements or expulsions occurred, which indicated a good retention of the frameless device. This innovative retention method of the frameless intrauterine device ensures a well-tolerated, long-term contraception, allowing for immediate contraception and proper pregnancy spacing for cesarean scar healing, and overcomes the issue of expulsion encountered with conventional intrauterine systems.

Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 – a secondary analysis of the EURAS-IUD study

Objective To conduct a secondary analysis of continuation, unwanted effects and cost consequences at 1 year in copper intrauterine device (IUD) users aged under 30 in the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD study) based on IUD type. Methods Descriptive and comparative analyses of copper IUD continuation, unwanted effects and estimated cost consequences at 1 year were performed in users aged under 30 based on IUD copper surface area, shape or design, width and arms’ flexibility. Results 5796 copper IUD users were identified to have been aged under 30 at EURAS-IUD study recruitment and data for 5762 users (99.4%) was analysed. Higher IUD continuation, fewer unwanted effects and lower costs were observed with IUDs of the lowest copper content (<300mm2), horse-shoe frame design, widths 18 mm to <30mm and flexible IUD arms. Discontinuation, unwanted effects and costs were greater with frameless IUDs and framed, ≥30mm width IUDs with 380mm2 of copper and copper bands on their rigid transverse IUD arms. Conclusions Significant differences in continuation, reported unwanted effects and estimated costs at 1 year between IUD types were observed in users aged under 30. Although further research is needed, clinicians should consider these findings when counselling and choosing IUD types for younger women.

Dimensional analysis of the endometrial cavity: how many dimensions should the ideal intrauterine device or system have?

BackgroundThe geometrical shape of the human uterus most closely approximates that of a prolate ellipsoid. The endometrial cavity itself is more likely to also have the shape of a prolate ellipsoid especially when the extension of the cervix is omitted. Using this information and known endometrial cavity volumes and lateral and vertical dimensions, it is possible to calculate the anteroposterior (AP) dimensions and get a complete evaluation of all possible dimensions of the endometrial cavity. These are singular observations and not part of any other study.MethodsThe AP dimensions of the endometrial cavity of the uterus were calculated using the formula for the volume of the prolate ellipsoid to complete a three-dimensional picture of the endometrial cavity.ResultsCalculations confirm ultrasound imaging which shows large variations in cavity size and shape. Known cavity volumes and length and breadth measurements indicate that the AP diameter may vary from 6.29 to 38.2 mm. These measurements confirm the difficulty of getting a fixed-frame intrauterine device (IUD) to accommodate to a space of highly variable dimensions. This is especially true of three-dimension IUDs. A one-dimensional frameless IUD is most likely to be able to conform to this highly variable space and shape.ConclusionThe endometrial cavity may assume many varied prolate ellipsoid configurations where one or more measurements may be too small to accommodate standard IUDs. A one-dimensional device is most likely to be able to be accommodated by most uterine cavities as compared to two- and three-dimensional devices.

Intrauterine levonorgestrel delivery with frameless fibrous delivery system: review of clinical experience.

The concept of using a frameless intrauterine device (IUD) instead of the conventional plastic framed IUD is not new. Frameless copper IUDs have been available since the late 1990s. They rely on an anchoring system to retain in the uterine cavity. The clinical experience with these IUDs suggests that frameless IUDs fit better as they are thin and, therefore, do not disturb or irritate the uterus. High tolerance and continuation rates have been achieved as complaints of pain are virtually nonexistent and the impact on menstrual blood loss is minimal. Conventional levonorgestrel-releasing intrauterine systems (LNG-IUSs) are very popular as they significantly reduce menstrual bleeding and provide highly effective contraception. However, continuation of use remains problematic, particularly in young users. Total or partial expulsion and displacement of the LNG-IUS also occur too often due to spatial incompatibility within a small uterine cavity, as strong uterine contractions originate, attempting to get rid of the bothersome IUD/IUS. If not expelled, embedment ensues, often leading to chronic pain and early removal of the IUD/IUS. Several studies conducted recently have requested attention to the relationship between the LNG-IUS and the endometrial cavity. Some authors have proposed to measure the cavity width prior to inserting an IUD, as many uterine cavities are much smaller than the currently existing LNG-IUSs. A frameless fibrous drug delivery system fits, in principle, in all uterine cavities and may therefore be preferable to framed drug delivery systems. This review examines the clinical performance, acceptability, and potential of the frameless LNG-IUS (FibroPlant®) when used for contraception, treatment of heavy menstrual bleeding, dysmenorrhea, and endometrial suppression in women using estrogen replacement therapy, endometrial hyperplasia, and other gynecological conditions. The review concludes that FibroPlant LNG-IUS offers unique advantages in reducing side effects.

Adolescent Intrauterine Contraception: IUD Size and Comfort during Insertion are Essential (IUD use in adolescents)

Background: Unintended pregnancies and induced abortion in adolescent women are soaring. The use of longacting reversible contraceptives (LARC), particularly the intrauterine device (IUD) and implant, are advocated as they don’t require daily adherence. Objective: To provide expert advice on the use of IUDs in young nulliparous and adolescent women in order to maximize continuation of use of the method. Results: Clinical studies suggest that high continuation of use of an IUD can be achieved by giving attention to the geometric relationship between the IUD and the host uterine cavity. Frameless IUDs virtually eliminate pain complaints and embedment caused by too large IUDs resulting often in early discontinuation. Conclusion: Appropriate intrauterine devices could enhance continuation of use and result in fewer unintended pregnancies and induced abortions. It is imperative to attach importance to comfort during device insertion to motivate young women to use the method.

The anchor of the frameless intrauterine device does not migrate over time: an analysis in over 300 women

Objective: To evaluate the correct position of the anchor at insertion and follow-up and assess if migration of the anchor occurs over time. Materials and methods: This was an insertion-related prospective postmarketing study in 309 women. Following insertion women were followed up at 4-6 weeks 6 months and yearly thereafter. The position of the visualized anchor in the fundus of the uterus was evaluated using ultrasound by measuring its distance from the serosal surface of the uterus (SA-distance). Results: A total of 309 parous (n=115) and nulliparous (n=194) women were fitted with the frameless GyneFix 200 or the GyneFix 330 intrauterine device for contraception. The mean SA-distance in 306 parous and nulliparous women was 6.0 mm (range 2.0-24.0 mm) at insertion in the parous group and 5.4 mm (range 1.3-11.0 mm) in the nulliparous group. At the first follow-up in 281 women the SA-distance was 6.0 mm (range 2.0-12.0 mm) in the parous group and 5.5 mm (range 1.1-11.0 mm) in the nulliparous group. The SA-distance was not significantly different. One patient had an exceptionally large SA-distance of 24 mm probably due to insertion in the posterior wall. No follow-up could be done in this patient. In 77 women the SA-distance was measured up to 42 months. The mean SA-distance at insertion in the parous group was 5.2 mm (range 3.0-8.5 mm) and 4.8 mm (range 1.3-7.0 mm) in the nulliparous group. At the last follow-up up to 36 months or longer the SA-distance was 5.1 mm (range 3.0-8.5 mm) in the parous group and 4.9 mm (range 1.3-7.0 mm) in the nulliparous group. The SA-distance was not significantly different. The visualized anchor was highly visible on ultrasound in all cases. Conclusion: The visualized anchor is a key element in the optimization of frameless technology with the aim of allowing the provider to check its placement at insertion and at follow-up which enhances provider confidence and assurance. The authors recommend measuring the thickness of the fundus prior to inserting the frameless intrauterine device and to measure the distance between the serosa and the visualized anchor following insertion and at the first follow-up examination.

Assessment of copper corrosion from frameless copper IUDs after long-term in utero residence

ObjectiveTo assess the site-specific corrosive behavior of the frameless intrauterine device (IUD) following long-term exposure to the uterine environment. Study designA qualitative and morphological study using X-ray diffraction (XRD) and scanning electron microscopy (SEM). ResultsThree GyneFix® IUDs that were in site up to 150months were examined. In utero corroded copper sleeves were divided into 10 different groups based on their shape (U or O), orientation (inside or outside) and in utero residence time. XRD indicated the presence of solely cuprite (Cu2O) as corrosion product on both the inside and the outside of the copper sleeves, regardless of their shape. These results were confirmed by backscattered electron micrographs recorded on the inside, the outside and the cross-section of the IUD sleeve. SEM results suggest that shape and orientation slightly affect the corrosion rate. ConclusionThe apparent copper loss from both sides of GyneFix copper tubes proves that both sides are a potential copper source and therefore justifies the design of GyneFix IUD. This could be beneficial for women as the IUD could be reduced in size and therefore better tolerated. The impact on bleeding could also be minimized. Implication statementRelease of copper ions from both sides of the copper tubes of the frameless GyneFix® IUD allows the IUD to be reduced in size, contributing to better toleration. The impact on menstrual bleeding is also minimized by a smaller size of the foreign body.

Frameless versus classical intrauterine device for contraception

The frameless intrauterine device (IUD) dispenses with the frame in the classical IUD and holds the device in the uterus by anchoring one end of a nylon thread in the fundal myometrium, to which copper sleeves are attached. This review examines the hypothesis that the frameless IUD Gynefix reduces risk of expulsion and pregnancy, and the problems of bleeding and pain necessitating early removal. We searched the Cochrane Controlled Trial Register (Cochrane Library Issue 2, 2004), MEDLINE, and Popline from 1980 to March 2004, and reference list of articles. We selected for the review randomised trials that compared the frameless device to a classical framed device for contraception. Both authors extracted data independently. We contacted study author for additional data. We calculated rate ratios and rate differences for cumulative rates for each outcome at yearly intervals. We used the inverse variance-based method to combine trials, and tested the results for heterogeneity. Four trials were included in the review involving 5,939 women randomised to either a frameless device or TCu380, with data up to eight years for the largest, and with a total experience of 23,180 years. Apart from one small trial, nulliparous women were excluded from the trials. The two earlier trials used a prototype introducer and there was a higher expulsion rate at one year (relative risk 2.48, 95% confidence intervals 1.89 to 3.26). However, between two and six years in the large WHO trial the risk of pregnancy was lower with the frameless device (relative risk 0.53, 95% confidence intervals 0.32 to 0.91). In a recent trial using GyneFix with a new introducer early expulsions and pregnancies were not statistically different from the control device. Removals rates for excessive bleeding and/or pain were no different between the devices (relative risks 0.92, 95% confidence intervals 0.74 to 1.14, at one year and 1.13, 0.93 to 1.37, at six years). There was a tendency towards fewer removals for pain in early years but no difference at six years (relative risk 1.13, 95% confidence intervals 0.93 to 1.37). There is insufficient data to show that problems of early expulsions have been overcome with the modified introducer used in GyneFix. Apart from that, the frameless device performs similarly to TCu380, and appears to have a lower pregnancy rate in later years, although the absolute difference is small.

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm 2 and the frameless levonorgestrel-releasing intrauterine system

Objective This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm 2 (GyneFix®; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 μg per day (FibroPlant™-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. Methods In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. Results MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. Conclusions The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.

Return to fertility in nulliparous and parous women after removal of the GyneFix® intrauterine contraceptive system

Objective: To evaluate the return to fertility following removal of the GyneFix® intrauterine implant system in women wishing to conceive.Study design: A retrospectivestudy was performed on a sample of healthy, sexually active nulligravid/nulliparous and parous women. The participants were 18-41 years of age, with no apparent infertility problem, living in a stable relationshipand planning to become pregnant. Women who changed their mind and did not wish to become pregnant immediately after intrauterine device (IUD) removal were excluded from the study. Women were evaluated interms of rates of conception and fertility outcome. A total of 128 women were evaluated.Results: The study shows that 119 out of 128 (93%) past users of GyneFix have conceived, accounting fora net cumulative pregnancy rate of 88% at 12 months and 99% after 2 years' observation. No statistical differences in pregnancy rates were found for age and duration of use of the IUD. A strong significantdifference in pregnancy rate was shown (p = 0.007) between parous and nulligravid/nulliparous women.Seventy-seven women (66.9%) gave birth to a term infant. There were no stillbirths. Twenty-fivewomen (21.8%) are pregnant at the time of writing. Five (4.4%) spontaneous abortions occurred and in eight women (6.9%) the pregnancy was terminated. There were no ectopic pregnancies.Conclusion: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/nulliparousand parous women wishing to become pregnant following removal of the device. Nulliparous women conceive significantly earlier than parous women.

Frameless versus classical intrauterine device for contraception.

The frameless intrauterine device (IUD) dispenses with the frame in the classical IUD and holds the device in the uterus by anchoring one end of a nylon thread in the fundal myometrium, to which copper sleeves are attached. The introducer for the frameless device was modified following reports of early expulsions of the device. This review examines the hypothesis that the frameless device reduces risk of expulsion and pregnancy, and the problems of bleeding and pain necessitating early removal. We searched the Cochrane Controlled Trial Register (Cochrane Library Issue 1, 2001), MEDLINE, EMBASE and Popline to Dec 2000, and reference list of articles. We selected for the review randomised trials that compared the frameless device to a classical framed device for contraception. Both authors extracted data independently. We contacted study author for additional data. We calculated rate ratios and rate differences for cumulative rates for each outcome at yearly intervals. We used the general variance-based method to combine trials, and tested the results for heterogeneity. Three trials were included in the review involving over 5,800 women randomised to either a frameless device or TCu380A, with data up to eight years for the largest, and with a total experience of 23,000 women-years. All three trials excluded nulliparous women. The two earlier trials used a prototype introducer and there was a higher expulsion rate at one year (relative risk 2.48, 95% confidence intervals 1.89 to 3.26). However, between two and six years in the large WHO trial the risk of pregnancy was lower with the frameless device (relative risk 0.53, 95% confidence intervals 0.32 to 0.91). In a recent trial using GyneFix with a new introducer early expulsions and pregnancies were not statistically different from the control device; by the third year the expulsion rate with the frameless device was lower (relative risk 0.41, 95% confidence intervals 0.19 to 0.87) with no difference in pregnancy rate. Removals rates for excessive bleeding and/or pain were no different between the devices (relative risks 0.92, 95% confidence intervals 0.74 to 1.14, at one year and 1.13, 0.93 to 1.37, at six years). There was a tendency towards fewer removals for pain in early years but no difference at six years (relative risk 1.13, 95% confidence intervals 0.93 to 1.37). There are insufficient data to show that problems of early expulsions have been overcome with the new introducer used in GyneFix. Apart from that, the frameless device performs similarly to TCu380A, and appears to have a lower pregnancy rate in later years, although the absolute difference is small.

Immediate postabortal insertion of the frameless IUD: review of current experience

Experience with the frameless Gynefix intrauterine device (IUD) for immediate postabortal insertion is growing. Reports confirm that the design characteristics of the frameless IUD (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high continuation rates. Insertion is easy and safe in the hands of trained providers and appears to be as reliable and effective as when inserted at interval. The results suggest that the frameless IUD may be an important new and affordable option to prevent repeat abortion.

Randomized comparative trial in parous women of the frameless GyneFix® and the TCu380A intrauterine devices: long-term experience in a Chinese family planning clinic

To compare the clinical performance of two intrauterine devices (the frameless GyneFix intrauterine device (IUD) and the TCu380A IUD) during long-term use. This was a randomized comparative study. A total of 157 insertions of the GyneFix IUD were compared with 156 insertions of the TCu380A IUD in the Tianjin Municipal Institute for Family Planning, China. Only parous women were included in the study. Insertions were conducted by the first three authors. The trial extended over a 9-year period, with over 10,000 woman-months of experience. The study showed that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0), compared to one pregnancy with the TCu380A IUD (cumulative pregnancy rate 0.64). The cumulative expulsion rate with the GyneFix IUD was 1.91 (three expulsions occurred, two of which were during the first 6 months), compared to a cumulative expulsion rate of 5.13 (eight expulsions) with the TCu380A (p = 0.1112). The total use-related discontinuation rate (terminations were mainly due to bleeding disturbances) was significantly lower (p = 0.0051) with the GyneFix IUD (4.46) than with the TCu380A IUD (14.10) and resulted in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (92.36 versus 83.97). Neither perforations nor cases of pelvic inflammatory disease were encountered with either device in this study, demonstrating the safety of the anchoring system. The results of the present clinical trial are in agreement with the findings of other multicenter, randomized, comparative, clinical trials that have investigated these two IUDs in China, as well as with the findings of other large-scale international studies conducted with the frameless IUD.