Howard J. Tatum

Metallic copper as an intrauterine contraceptive adjunct to the “T” device

605 women were inserted with plain T-IUDs, 508 patients were inserted with TCu-A devices, and 279 women were inserted with TCu-B devices. In the TCu-A, a 2 cm length of copper wire of .5 mm diameter was wound around the upper aspect of the vertical arm of the T-IUD. In the TCu-B, a 6 cm length of wire of .15 mm diameter was coiled downward over a 1 cm distance. The surface area of copper was 30 mm in both prototypes. The data derived from the 3 series of patients were tabulated and analyzed utilizing the Life Table method of Tietze. Endometrial biopsies were obtained from randomly selected patients. Results showed that after 2 years of use, the plain T device had a significantly lower rate of metrorrhagia than had been reported for any other contraceptive device. The rate was approximately 6 times less than that observed with the Lippes loop D. Pain was a negligible cause for closure during the 2 year period. The T device had a rate of pregnancy of 24.3 which is 6 times the pregnancy rate of the Lippes loop D. The first expulsion rate was 4.5, but the rate for later expulsions was .4. When a small qlantity of copper was added to the T there was a dramatic and highly significant reduction in the rate of pregnancy. At the end of 2 years of use the rate was 9.8 for the TCu-A. Other clinical parameters also were apparently modified by the metallic copper. The expulsion rate was reduced, the rate of metrorrhagia was slightly increased, and the rate of pain may have been increased. During the same lenght of time the rate of removal for loop D because of bleeding and/or pain is approximately 3 times greater than for the T with copper. Reductions in both expulsion and removal rates of TCu because of medical reasons constituted the principal factors accounting for the continuation rate of 77.6 as compared with 65.6 for loop D at the end of 2 years of use.

Management and outcome of pregnancies associated with the Copper T intrauterine contraceptive device

The clinical outcome of 918 pregnancies in women who conceived while using one or another of four models of the Copper T intrauterine contraceptive device (IUD) is presented. Elective abortion was chosen by 58 per cent of the women. The clinical management and course of 275 women who elected to allow their unplanned pregnancy to continue are described. The Copper T was either expelled or extracted during the pregnancy in 118 of the women, while the IUD remained in situ for the duration of the pregnancy in the remaining 157 patients. The incidence of spontaneous abortion more than doubled when the IUD remained in utero. The chance of a live birth being premature was four times greater when the IUD remained in situ than when it was removed. There were 27 ectopic pregnancies in this entire series, giving an incidence of 3.4 per cent. In addition, the data suggest, but do not prove, that there is an increased risk of having an ectopic pregnancy if the woman has worn the Copper T for more than two years. A benign fibroma of the vocal cord was the only congenital anomaly detected. These observations suggest that the incidence of developmental defects is not adversely affected by the presence of intrauterine copper.

A study of the antifertility effect of intrauterine copper

Abstract The addition of a small quantity of metallic copper to an “inert” intrauterine contraceptive device has been shown by Zipper et al . (1) to enhance greatly the antifertility effect of the device. The two experiments described in this report were planned to elucidate the mechanism of contraceptive action of copper in the rat. In the first experiment, fertilized ova which had shared the intrauterine milieu with a segment of copper wire for 2–4 days and designated as copper-“influenced” blastocysts, were collected on day 5 of pregnancy and transferred into one uterine horn of a normal pseudopregnant recipient rat. Normal non-copper-“influenced” blastocysts were transferred into the other uterine horn which served as the control. The blastocysts in both recipient horns implanted and developed normally. In the second experiment, normal blastocysts were transferred into a uterine horn of a pseudopregnant rat which had contained a segment of copper wire for 3 days prior to the day of blastocyst transfer. The opposite uterine horn had not been “influenced” by copper, and thus served as the control. None of the blastocysts implanted in the copper-“influenced” horns, whereas normal implantation and development occurred in the non-copper-“influenced” contralateral horns. A copper-“influenced” blastocyst can be transferred into a normal uterus where it will implant and develop normally. The antifertility effect of intrauterine copper in the rat seems to be due to a local change in the intrauterine environment such that the blastocyst does not implant.

Metallic copper as an intrauterine contraceptive agent.

Abstract Some of the biological aspects of copper relevant to reproductive processes are reviewed. Included are cyclic variations in the concentrations of copper in the endometrium, uterine fluid, cervical mucus, and serum as modified by the presence of intrauterine metallic copper and after its removal. Variations in the endometrial enzymes, namely, α-amylase, glycogen synthetase, and phosphorylase, are also considered. The rate of copper loss from the intrauterine copper T in the woman is reviewed, and these data are considered in relation to the duration of effective antifertility action within the uterus. In addition, the theoretical participation of this quantity of copper in the total body metabolic balance of copper is considered. Special reference is made to Wilsons disease. Examples of surface changes in the copper wire which may occur during its intrauterine life are described. The potential implications of copper fragmentation are considered, and relevant experimental data obtained from rhesus monkey studies are presented. The latest clinical data on use-effectiveness of the copper T Models 200 and 300 in nulligravidous, nulliparous, and parous women in the United States and abroad are presented. In addition, a preliminary report is made on a double-blind comparison of the T Cu 200 and the Copper 7 after 9 months of use.

Four years of experience with the TCu 380A intrauterine contraceptive device

A study of the United States acceptors of the Copper T, model TCu 380A, initiated in 1972, was carried to the completion of 4 years of observation. The 1051 receptors, whose median age was 22.3 years, accumulated a total of 1927 years of use. At the end of 4 years, the cumulative net pregnancy rate was 1.9 per 100 women, and the gross rate was 2.8 per 100. The annual continuation rate over the 4-year interval averaged 77 per 100. The TCu 380A intrauterine device (IUD) has provided extremely effective and undiminishing protection against pregnancy through 4 years of use in a group of young women. This degree of protection has not as yet been equaled when randomized comparative trials have been carried out with other copper-bearing IUDs.

A simple nonsurgical technique to obtain unimplanted eggs from human uteri.

Abstract A technique to obtain unimplanted eggs from the human uterus in situ is presented. The eggs are washed out of the uterine cavity with sterile saline by means of a transcervical two-way stainlessisteel cannula designed for this purpose. Six ova and one possibly fertile egg were obtained by this technique and are described. Suggestions are made for the application of this technique to the study of some fundamental aspects of human reproduction.

Longterm contraception by subcutaneous silasticR capsules containing megestrol acetate

Abstract Contraceptive effectiveness and acceptability of subcutaneous silastic capsules containing Megestrol Acetate (M.A.) were evaluated in 188 women of childbearing age. The patients were observed for a minimum of 2 and a maximum of 18 months. A total of 1,448 cycles were recorded. In patients bearing 4 implants eleven pregnancies were reported during 1,076 months of use. No pregnancies occurred in the group of patients bearing 5 capsules, during 372 months of use. Data are presented which suggest that in most patients in both groups conception is prevented without inhibition of ovulation.

Morphological studies of Dalkon Shield tails removed from patients

Abstract Examination of the tails of Dalkon Shields removed from patients showed that approximately 34% of the tails had breaks or holes in the nylon sheath immediately below the double knot at the base of the Shield. The location of these holes is such that most of them would have been within the endometrial cavity. For control purposes, unused sterile Shields were removed from their pouches, and the tails were inspected for breaks in the sheath. Breaks were found in approximately 9% of these. Most of the holes were in the same location as those seen in tails removed from patients. The internal contents of the short terminal segments of Dalkon tails located beyond the double knot, from Shields removed from patients, were studied. Thirty-five (35) segments were evaluated by phase contrast microscopy and 10 were studied subsequently by transmission electron microscopy. Bacteria were found within the interfilamental spaces inside the sheath of 8 of the 10 tails. These observations suggest that bacteria which have ascended through the tail from the vagina could exit through these breaks in the sheath or from the terminal end of the tail directly into the endometrial cavity. The potential clinical implications of the data presented in this paper must be taken into consideration in the management of the non-pregnant asymptomatic wearer of a Dalkon Shield.

The first year of clinical experience with the Copper T intrauterine contraceptive system in the United States and Canada

Abstract A comparison of the clinical effects of the Copper T Model TCu 200 and Lippes loop D was made from a random selection of parous women in nine separate clinics in the United States and Canada. The data from 945 patients bearing the Copper T and 750 patients bearing Lippes loop D are reviewed after 12 months of use. A disparity between the results from one clinic and all the others is presented and a possible explanation is suggested. In general, the advantages of the TCu 200 over Loop D which have been suggested by previous preliminary clinical comparisons continue to be apparent, although the differences are becoming somewhat less marked as the magnitude of the data increases.

Further studies on long-term contraception by subcutaneous silasticR∗ capsules containing megestrol acetate

Abstract The contraceptive effectiveness of megestrol acetate (M.A.) implants was evaluated in 126 parous young women. Each patient received 5 implants. Each implant contained 23 mg of M.A. A total of 1,560 cycles were recorded. Only one pregnancy occurred in patients observed for up to 15 months for over 1,440 cycles. Three pregnancies occurred in a group of 20 patients whose capsules were replaced by a new set at the end of the first 15-month trial period. The variation in contraceptive effectiveness and the incidence of side effects of this method compared to other methods is discussed.