(A) study on intrauterine copper T contraceptive device
Since 1960's intrauterine devices(IUDs) have been used with varying degree of success in family planning and fertility control programs throughout the world. The history of intrauterine devices reaches back to ancient times when the
intracervical or intrauterine insertion of materials was practiced as a treatment of disease, an abortifacient or a contraceptive. The IUD by Richter, a flexible ring fashioned of silk worm gut, probably was the first practial IUD> Great
interest in IUD's began to develop after 1959 when Oppenheimer and Ishihama reported favorable results with regard to safety and effectiveness.
Although IUD is an effective and safe method of contraception, the problems of expulsion, removal and accidental pregnancy have remained to be solved. To improve IUD performance by reduction of the incidence of these three pertinent events, research has concentrated on the technical improvement, on evaluation of the device itself and on the addition of bioactive substances to the IUD to reinforce its contraceptive effect or to reduce its side efgfects. The copper IUD is known as the first practical bioactive device. Since Zipper demonstrated the antifertility
effect of copper in animal experiments in 1969, the advantages of adding copper have been reported in recent articles. Researchs on both animal and human suggest that the contraceptive effect of copper is the result of the release of copper ions into the uterine cavity where they may have various biochemical effects.
There have been several reports of x-ray studies of the shape of the copper IUD within the uterus and sporadic reports on the morphological effect of the copper IUD on the endometrium.
The study aims to evaluate the contraceptive effectiveness and morphological effect of the copper IUD on the endometrium. Also the localization of copper in the endometrium was investigated.
Materials and Methods
The intrauterine device used in this study was the copper T device, model TCu 200(Cu-t device).
A total of 6,130 women months of use were observed in 394 women selected randomly from new registrants at the Yonsei University Family Planning Clinic. Initial insertions were performed between October, 1971 and September, 1972. All cases using the Cu-T device were required to return to the clinic monthly for the follow up observation for the first three months and then once inevery three months. Also they were requested to return promptly when any porlbem arose. The lifetable method(Smith et al., 1972) was used for measuring the continuation, termination, expulsion, removal and pregnancy rates.
In 316 women anterior-posterior and lateral x-rays of the pelvis were obtained to determine the shape of the Cu-T device immediately after insertion. The shapes of the device in the uterus were classified into four groups depending upon the
relations of the transverse and vertical arms: "T", "↑", "??" & "??" and "??" & "??". In 36 cases random x-ray examinations were repeated 3-24 months after insertion to evaluate any change of the shapes as compared with the initial x-ray findings
50 women using the Cu-T device for a period of 9-28 months were selected randomly out of 394 cases. For the controls, 55 women of the reproductive age group were selected who were healthy and had had no evidence of any disease. These had the histological and histochemical studies of the endometrium. The materials were
obtained from the anterior and posterior wasll of the uterine cavity using Novak curette. The biopsy specimens were immediately fixed in 10 percent neutral formalin solution, embedded in paraffin, sectioned and stained with hematoxylin-eosin, periodic acid Schiff, alcian blue and methyl green pyronin. The Timm's copper stain was done to determine the localization and distribution of copper in the endometrium. The dating of endometrium was performed according to the method described by Noyes et al. (1951).
Results and Summary
1. The cumulative net pregnancy rate was 0.010 during 6,130 women months of use.
2. 56.6 percent of the acceptors complained of side effects, but no seerious consequences were observed. The side effects were most notable during the first few months after insertions, usually diminishing or disappearing after the third month
of use. The cumulative continuation rate to start of month was 0.669 at the end of twelfth month and 0.508 at the end of twenty fourth month. The cumulative net expulsion rate was 0.131 at the end of twenty fourth month. At the end of twenty fourth month the cumulative net removal rate was 0.189 for bleeding and pain, and
0.160 for otheer than medical reasons.
3. 24.3 percent of cases having repeated x-ray examinations demonstrated minimal to mode rate changes in the transverse arms of the Cu-T device in the uterus. No extremely abnormal shape of the Cu-T device was demonstrated.
4. After the periods of exposure to the Cu-T device, ranging irom 9-28 months, some changes of endometrial morphology were seen. These were characterized by infiltration of inflammatory cells into the glandualr lumina, hypermia, edema and decidual formation of stromal cells. These tissue reactions were not specific for the Cu-T device. This study revealed no evidence of a carcinogenic effect of the device to the endometrium. No characteristic to chemical reaction was observed. In 24.0 percent of biopsy speciments copper was localized in the glandualr and
epithelial cells and no cellular damage was seen.
In conclusion the study shows that a copper T device, model T Cu200, is effective and safe, and this device can be an accepted method of contraception.