Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS.

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study.

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.

PIP: An IUD. releasing approximately 20 mcg/day of levonorgestrel (LNg 20) was studied in a randomized trial of 5 years duration. 1124 women comprised this group and were compared to another group of 1121 women who used the TCu 380 Ag. At the end of 5 years, the gross cumulative pregnancy rate was 1.1 +or- 0.5/100 among LNg 20 devise users; this was not significantly different from the rate of 1.4 +or- 0.4/100 experienced by those using the TCu 380 Ag. The steroid-releasing IUD had significantly higher rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The 5-year continuation rate among women using the TCu 380 Ag was 40.6/100 as compared to 33.0/100 among women randomized to the LNg 20 device (p0.001). Terminations attributed to amenorrhea with the LNg device are largely responsible for the differences in continuation.

Two years of intrauterine contraception with levonorgestrel and with copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices.

IUDs releasing 20 mcg/day of levonorgestrel (LNg20) were in randomized trial together with the Copper T, model TCu 380Ag, in seven centers involving 2244 women. Two-year (25 months) gross cumulative pregnancy rates were 0.2 +/- 0.2 and 0.9 +/- 0.3 for the levonorgestrel and copper releasing devices, respectively (P greater than 0.05). There were no ectopic pregnancies in more than 1600 woman-years of use of each device. Removal rates for bleeding and/or pain or for medical reasons other than menstrual problems did not differ significantly between devices. Oligomenorrhea or amenorrhea prompted 10.7 per hundred (gross rate, 8.4 net rate) women using the LNg 20 IUD to request removal in the two-year period, significantly above the 0.2 per hundred rate among women with the Copper IUD (P less than 0.001). At the end of two years an estimated 59.4 per 100 women were continuing use of the LNg 20 IUD, and 67.5 per 100 (P less than 0.001) with the TCu 380Ag. This difference is almost wholly ascribable to a marked reduction in bleeding episodes and days among women using the LNg 20 device with concomitant removal of device. Hemoglobin rose an average of 0.5 g/dl (P less than 0.001) for this group whereas women using the TCu 380Ag experienced a decline of 0.2 g/dl compared with baseline values (P less than 0.001).

PIP: An IUD releasing 20 mcg/day of levonorgestrel (LNg20) was compared with a Copper T IUD (TCu 380 Ag) in a randomized trail involving 2244 women 7 centers in the US, Brazil, Egypt, Chile, Singapore, and the Dominican Republic. The cumulative gross pregnancy rate at 2 years was 0.2 for the LNg 20 device and 0.9 for the TCu 380 Ag IUD. There were no ectopic pregnancies in more than 1600 woman-years of use of each device. The removal rates due to oligomenorrhea or amenorrhea were 10.7/100 among LNg 20 acceptors compared with only 0.2/100 among TCu 380 Ag acceptors in the 2-year study peroid. Removal rates for pain and/or bleeding did not differ significantly between devices. Hemoglobin rose an average of 0.5 g/dl in the LNg 20 group and declined an average of 0.2 g/dl in the TCu 380 Ag group. At the end of 2 years, the continuation rates were 59.4/100 among LNg 20 acceptors and 67.5/100 among TCu 380 Ag acceptors. This difference is ascribable to the scanty and infrequent bleeding patterns associated with the former device. It is concluded that both these IUDs provide highly effective intrauterine protection.

Intrauterine contraception with copper and with levonorgestrel: a randomized study of the TCu 380Ag and levonorgestrel 20 mcg/day devices.

First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.

Long-term luteal changes after tubal sterilization.

In this study the luteal function was evaluated in 109 subjects 2 to 108 months following tubal sterilization by Pomeroy's technique or laparoscopic tubal rings. Midluteal endometrial biopsies determined by basal body temperature charts were performed and dated in all subjects. Midluteal serum progesterone was estimated by RIA in 40 women. Our results indicated that the mean time which had elapsed since sterilization was significantly shorter in the subjects who revealed luteal defects than in those with normal luteal function. There were no statistically significant differences between the 2 occlusive techniques in terms of poststerilization incidence of luteal defects.

Pelvic schistosomiasis and infertility.

The use of laparoscopy allowed us to diagnose asymptomatic pelvic schistosomiasis in 13 infertile women. The lesion was associated with dense pelvic adhesions in all cases, a defective luteal phase in 23.1% of the women and anovulation in 15.4%. Atraumatic adnexolysis, antibilharzial treatment and correction of ovulatory defects were followed by intrauterine pregnancy in 46% of the patients.

PIP: Laparoscopic diagnosis of pelvic schistosomiasis and the possible effects of this lesion on fertility were examined at the Ain Shams University Hospital in Cairo, Egypt over the 1977-1980 period. All infertile patients who came from endemic areas were thoroughly investigated for schistosomiasis. During the first 2 years of the study, there were 13 patients aged 23-38 years with pelvic schistosomiasis. Exploration was undertaken in all cases and atraumatic adnexolysis was performed. In 3 patients myomectomy was also performed. Ovulatory defects were treated in 5 patients with 100-200 mg of clomiphene citrate administered daily for 5 days, beginning on the 2nd day of the menstrual cycle. In 2 women who failed to respond to a high dose of clomiphene citrate, Pergonal and human chorionic gonadotropins were used. Ambilhar was given to all patients for 6 days to treat schistosomiasis. The cervix was cauterized in 7 women who revealed bilharzial cervicitis. All patients were followed up for 15 months after treatment. All patients complained of primary infertility, the duration of which ranged from 4-14 years. Cervical erosion was present in 5 women, vaginal granulation in 2, and vaginal sandy patches in another 2 women. Pelvic examinations revealed the presence of coporel myomata in 3 patients. Cervicovaginal smears were positive for schistosomal ova in 3 patients. In all patients, the whole length of both fallopian tubes was visualized. These tubes revealed changes that indicated the presence of both periadnexal adhesion and intramural lesions. In all patients the uterine cavity was either normal sized or enlarged. The tubes were whitish, thickened, elongated and coiled. The ovary and the coiled ampullary portions of the tube were encapsulated in dense whitish adhesions. Methylene blue test confirmed the preservation of tubal patency. Bilharzial sandy spots and nodules were detected in all patients. Cervical biopsies revealed the presence of active or healed bilharzial cervicitis in 7 cases (53%). Repeated premenstrual endometrial biopsies showed normal secretory endometrium in 8 women, defective luteal phase in 3 women, and anovulation in 2 women. Laparoscopic biopsies showed a characteristic active or healed bilharzial lesion. As a result of treatment, there were 6 normal intrauterine pregnancies (46.2%). In 1 woman, pregnancy ended in abortion during the 10th gestational week. Ectopic pregnancy was reported in only 1 woman (7.7%). The study results suggest that pelvic schistosomiasis among infertile women is probably much more frequent than previously thought. In about 50% of patients atraumatic adnexolysis, cauterization of cervical lesions, and correction of luteal defects may be followed by pregnancy.

Long-term intracervical contraception with a levonorgestrel device.

An intracervical levonorgestrel-releasing mini-T device was tried as contraceptive in 100 fertile multiparous women for 3 years. This device release about 10 micrograms/day. The results were compared with those of an intrauterine levonorgestrel device and copper-T-200 (Cu-T-200). The continuation rates of the three device did not reveal any significant differences at 1, 2 and 3 years. Incidence of unintended pregnancies and removals due to bleeding and pain was comparable to those of Cu-T-200 but higher than those of intrauterine levonorgestrel device. The number of days of bleeding and spotting for both levonorgestrel devices was significantly lower than those for Cu-T-200.

The norgestrel-T-IUD.

An improved long-acting Norgestrel-T contraceptive device has been developed. The effects of different release levels of levonorgestrel on the endometrium were studied in a selected group of 42 subjects. A randomized comparative study of the clinical performance of Cu-T 200 and Ng-T devices was undertaken in 200 fertile women for 15 months. Quantitation of the menstrual blood loss was performed on a selected group of 20 users. This new Ng-T device proved highly effective in fertility control. It was associated with a significant reduction in the amount of menstrual blood loss and incidence of termination probabilities due to bleeding and pain.

Body weight and cycle control of injectable contraceptives.

Five long-acting progestogens were tried as injectable contraceptives in 1,363 women for one to three years. A total of 22,304 woman-months were studied. The first injection was given either within five days of the onset of the menstrual cycle or during the postpartum phase (330 women). The different factors that may influence cyclicity were analyzed. Among these factors, the following may be important: potency and dose of progestogen, addition of long-acting estrogen, pretreatment menstrual pattern, duration of therapy and body weight of users. The incidence of amenorrhea was higher in overweight than in underweight or normal subjects. The causal relationship can be explained by the storage of the absorbed progestogen in the adipose mass.

Progestogen treatment of uterotubal (cornual) block.

High dose progestogen was used to treat 112 cases of primary sterility due to uterotubal block, after tuberculosis and cornual myomata were excluded as causes of the condition. The duration of sterility ranged from three to 18 years. Patients were treated for six or 12 months, depending on their responses to the drug. The results of treatment were very favorable; bilateral and unilateral patency was achieved in 74.0% and 11.6% of the patients, respectively. Pregnancy occurred in 42.8% of all cases studied.

Galactorrhea and the defective luteal phase of the menstrual cycle.

Twelve patients with primary infertility due to a defective luteal phase associated with hyperprolactinemia and galactorrhea are reported. All were treated with 2-bromoergocryptine. During the first cycle of therapy, the serum prolactin level decreased in all cases, and galactorrhea disappeared during the second cycle of therapy. Seven women responded to 2-bromoergocryptine, as was reflected in their endometrial biopsies. The remaining five were given clomiphene citrate on the second and sixth days of the next 2-bromoergocryptine cycle. Three of these patients responded favorably to this combined therapy. Six pregnancies were reported during therapy. The results of follow-up after labor or abortion suggested that these cases represent a latent stage of the amenorrhea-galactorrhea syndrome.

Unification of a septate uterus: Mahgoub's operation.

A simple surgical technique for unification of a septate uterus is described. The septum and a small strip of fundus are removed with scissors inserted through two small fundal stabs, and the opening is closed with one mattress suture, which forms an anteroposterior suture line no more than 1 cm long. At the end of the operation an intrauterine contraceptive device is inserted to prevent uterine adhesions. The operation has several advantages: (a) it leaves a capacious uterine cavity of normal appearance, (b) it avoids large uterine incisions, and thus the possibility of postoperative adhesions or weak uterine scars, and (c) it avoids possible injury to the cornual ends of the Fallopian tubes. This article reports favorable results in 17 women treated with this surgical technique.