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Intrauterine contraception with Nova-T and copper-T-200 during three years.

A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p less than 0.001). Copper-T had a lower expulsion rate (p less than 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not effected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity then the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.

Adult↗

Copper loss from the copper T model TCu22OC.

The effect of mineral deposits on the copper dissolution rate of the Copper T Model TCu22OC was examined. 118 Copper T22OC devices removed from subjects for various medical and personal reasons after 12 to 72 months in utero were examined and graded based on the proportion of the total copper area covered with mineral deposits. The deposits increased in average size during the first three years of IUD use and then remained relatively constant. Seventeen percent of the devices were in situ for four or more years. Copper analysis was performed on 30 Copper T 22OC devices from selected periods of use : 12-14, 22-26, 36-39 and 48-72 months of use. The mean daily copper loss was 29.4 micrograms and the range, 7.3 to 62.1 micrograms. An inverse correlation between the amount of mineral deposit on the copper surface and the rate of copper loss was observed.

Copper↗

Clinical performance of a new levonorgestrel-releasing intrauterine device. A randomized comparison with a nova-T-copper device.

The clinical performance of two levonorgestrel-releasing intrauterine devices (IUDs) with different release rates was studied and compared with a copper-releasing Nova-T device in a randomized partly double-blind multiclinical trial. Special attention was given to patterns of bleeding, hormonal side-effects, blood pressure and body weight. The clinical acceptability of the levonorgestrel IUDs was as good as that of the copper-releasing IUD. A highly significant decrease in the amount of menstrual blood loss was seen with the levonorgestrel-IUDs, the users of which experienced fewer days of bleeding than prior to insertion. Patients suffering from dysmenorrhea experienced relief from this symptom after insertion of a levonorgestrel-IUD. Some side-effects, usually referred to as hormonal, increased during the levonorgestrel-IUD use, but did not result in higher termination rates than with the Nova-T device. No changes in body weight were recorded for the levonorgestrel-IUDs and a slight decrease in both systolic and diastolic blood pressure was found after one year of use. No infections were recorded.

Adolescent↗

Predictive value of serum ferritin in anemia development after insertion of T Cu 220 intrauterine device.

A one-year follow-up study in 30 healthy women was undertaken to study serum ferritin as well as other hematological parameters prior, six and twelve months after insertion of an intrauterine device, T Cu 220. Women were allocated into one of two groups according to the baseline ferritin serum levels; Group I abnormal ferritin and Group II normal ferritin levels. Other hematological parameters were normal and no iron supplement was given throughout the study. A direct relationship between low ferritin serum values (Group I), and anemia development was found. Seven out of 15 developed anemia, whereas only 2 out of 15 had anemia at twelve months in Group II with normal ferritin values. The overall data suggested that measurement of serum ferritin levels could be a useful tool to anticipate anemia development in women with intrauterine devices.

Adult↗

Corrosion of filamentous intra-uterine copper. The MLCu250 and the MLCu375.

Although the effective life span of an IUD provided with filamentous copper is, calculated on the basis of the rate of dissolution of copper, several years, corrosion may lead to breakage of the wire after a shorter period of use. When copper wire with a diameter of 0.20 to 0.25 mm is used, the proportion of IUDs with broken wires increases with time after three years of use. It was not known whether this disadvantage could be reduced or eliminated by the use of a thicker wire. In this study the corrosion behaviour was observed in MLCu250 and MLCu375 devices, which have copper wire with a diameter of 0.30 and 0.40 mm, respectively. The earliest breakage was observed after 8 months of use for 0.30 mm wire and after 9 months of use for 0.40 mm wire. In IUDs with 0.30 mm wire the proportion with broken wires increased after 3 years of use. Since examples of the MLCu375 with 0.40 mm wire used for more than 3 years were few, it was impossible to make definite conclusions in this respect. In general, the corrosion behaviour in copper diameter range of 0.3 to 0.4 mm is the same as indicated in previous studies for diameter range of 0.2 to 0.25.

Corrosion↗

Corrosion behavior of copper/LDPE nanocomposites in simulated uterine solution.

We prepared copper/low-density polyethylene (LDPE) nanocomposites with various mass fractions of copper nanoparticles and investigated the Cu(2+) release rate of them for 220 days in a simulated uterine solution .The influences of copper nanoparticle mass fraction on Cu(2+) release and volume resistivity confirm that continuous network of copper nanoparticles can be obtained in composites when copper nanoparticle mass fraction ranges from 30% to 35%. Scanning electron microscopy with energy dispersive X-ray microanalysis (SEM/EDX) mapping technique was employed to investigate the copper distribution and corrosion depth of 30 wt% copper/LDPE composite before and after incubation. Besides, elements and phases were also analyzed by EDX and X-ray diffraction, respectively. The results suggest that copper/LDPE nanocomposites should be more efficient and feasible than conventional IUD materials.

Biocompatible Materials↗

The effect of intrauterine devices containing zinc and copper on their levels in serum.

Serum levels of copper and zinc were determined in 11 health women in whom Latex Leaf intrauterine devices (IUDs) containing copper and zinc had been inserted. Patients with low levels of serum copper or zinc before insertion usually had increased levels of either of these metals while using the device, but they did not exceed the upper limits of normal values. When the group was considered as a whole, the serum levels of zinc showed a slight tendency to increase with duration of IUD use, whereas there was no statistical difference between the serum levels of copper before and after insertion of the IUD.

Adult↗

Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T.

A comparative study of the Progestasert (UPS) and the Nova-T in 326 randomly selected women was carried out. The observation period was 1 year. The over-all continuation rates for the two types of intrauterine devices (IUDs) were similar. The expulsion rate for the Nova-T (9.2%) was considerably higher (P = 0.001) than that for the UPS (1.2%). Medical removals for bleeding/pain were more frequent (P = 0.028) for the UPS (15.4%) as compared with the Nova-T (6.1%). The pregnancy rate for the UPS (Pearl index = 4.8) was insignificantly higher than that for the Nova-T (Pearl index = 2.8). Two of the pregnancies in the UPS group were ectopic. No significant changes in the reactive immunoglobulins (IgA, IgG, or IgM) were observed in either of the groups. Our results indicate that neither of these two IUDs is preferable to the already existing medicated IUDs, such as the Copper T or the Copper 7.

Adult↗

Serum copper in long-term users of copper intrauterine devices.

A study was undertaken to determine whether long-term use of a copper intrauterine device (IUD) was associated with any alteration in the serum copper levels and thereby whether absorption of copper from the device in utero could result in copper toxicity. Serial estimations in copper IUD wearers showed that there was no alteration in serum copper levels for a period of up to 24 months. The mean range and frequency distribution of serum copper levels in long-term copper IUD wearers was similar to that seen in the normal population. There was no difference in the mean 24-hour urinary copper excretion between the control group and the copper IUD wearers. Data suggest that the copper released from a copper IUD may not be readily absorbed from the uterine fluid. This hypothesis needs verification.

Copper↗

Ultrastructural changes in human endometrium with copper and nonmedicated IUDs in utero.

Scanning and transmission electron microscopy were used for a study of the surface and glandular ultrastructure of human endometrium in the presence of different types of IUDs at comparable phases of the menstrual cycle. The aim of the study was to compare the effect of the nonmedicated with the copper and multiload copper devices to further explain the differences in their contraceptive potencies and their mechanism of action. The endometrium was evaluated at and away from the IUD; emphasis was put on the ultrastructure of endometrial gland openings, secretory activity, cellular glycogen content, ciliated cells, microvillous pattern, and kinocilia. The changes of the surface ultrastructure of the endometrium in the presence of copper IUDs were more extensive in this study than those previously reported. There seems to be a direct relationship between the amount of copper incorporated in the device, the degree of ultrastructure changes, and the area of endometrium involved. Copper devices affect the endometrial cells away from the IUD. The altered secretory function with disturbed macroapocrine secretion, the abnormality of ciliated cells, and the defective microvillous growth seem to interfere with the physiologic and functional integrity of the endometrium, reducing the chances of contraception in the presence of copper IUDs.

Cilia↗

Concentrations of copper in human secretions and weight of the copper wire during the 4 to 7 years after insertion of a Cu-IUD (intrauterine device).

The useful life span of the two most commonly used copper intrauterine devices (Cu-IUDs) (Gravigard and Cu-T) was investigated in a long-term study up to 90 months after insertion. Minor differences between the two types of devices were found that, however, probably do not contribute to a diverging contraceptive efficacy with time. To be able to ensure maximal contraceptive effect, the authors suggest on the basis of the present data that the time of use not exceed 5 to 6 years.

Adolescent↗

The peritoneal reaction to the translocated copper intrauterine device in women and female rats.

The observation of a very severe peritoneal reaction to translocated copper-bearing devices in five women necessitated operative removal. Three Copper-T (Ortho Gyne-T, Ortho, Saunderton, High Wycombe, England) and two Copper-7 (Gravigard, Searle, High Wycombe, England) devices were involved. Similarly severe peritoneal reactions were noted in 90% of female rats who had small-sized modified copper devices inserted into their peritoneal cavities. In a control group of rats with the same device but without a copper wire, mild adhesions were observed in the majority (85%), and none had a severe peritoneal reaction. It seems evident that the severe peritoneal reaction is induced by the copper wire in both women and female rats.

Animals↗

[Cooper IUD and congenital malformation? (author's transl)].

A 23 year old, gravida O, conceived 18 months following insertion of a copper containing IUD. At 10 weeks; gestation the IUD was removed. At 42 weeks' gestation, an infant was delivered normally, with severe upper limb reduction deformities and other minor malformations. However, reviewing the literature the possible role of the IUD in the etiology of limb reduction deformities cannot be supported.

Congenital Abnormalities↗