Return of fertility following discontinuation of Norplant-II subdermal implants. ICMR Task Force on Hormonal Contraception.

A total of 627 women who had discontinued the use of the Norplant-II implants for various reasons and were exposed to the risk of pregnancy were followed-up for two years for return of fertility. The cumulative conception rates in women who had discontinued due to planning pregnancy were 80.3 per 100 women at one year and 88.3 per 100 women at two years. The majority of women who did conceive (90 percent), had full-term normal live births; about 4 percent of women had spontaneous abortions, the remaining 6 percent decided on elective termination of pregnancy (ETP). The cumulative conception rates in women who discontinued due to bleeding irregularities and 'other reasons' were 64.5 and 55.8 per 100 women at one year and 77.9 and 75.1 per 100 women at two years, respectively. These rates were significantly lower as compared to those observed in women who discontinued due to planning pregnancy. A large proportion, about 40 percent, of women who conceived after discontinuation of the method due to bleeding irregularities and "other reasons," opted for ETP indicating that many women in these two groups did not desire another child and that such women need to be counselled for adopting another method of contraception. The spontaneous abortion rates observed in ex-users of Norplant-II implants (1.7 to 4.4% pregnancies) were comparable to the spontaneous abortion rates prior to Norplant-II implant use (3.6% pregnancies) indicating that ex-users of Norplant-II implants were not at a higher risk of spontaneous abortion.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: Researchers at 15 Human Reproduction Centres of the Indian Council of Medical Research followed 627 women aged 18-35 who stopped using the subdermal Norplant-II system for different reasons, and thus were exposed to the risk of pregnancy, for 2 years to determine return of fertility. 20% conceived within 1 month of Norplant-II implant removal. The 6-month, 1-year, and 2-year pregnancy rates were 63.4%, 80.3%, and 88.3%, respectively. Neither duration of Norplant-II implant use nor bleeding patterns had an adverse effect on return of fertility. The 1-year and 2-year cumulative pregnancy rates for women who stopped due to bleeding irregularities and other reasons were lower than those who stopped due to planning a pregnancy. Return of fertility was delayed in women whose implants were removed after age 30 compared to those younger than 30 (1-year pregnancy rate, 66.3% vs. 83%; median time to conception, 6 vs. 3.8 months; p 0.05). The difference was not significant at 2 years, however. 89.7% of women who wanted pregnancy and became pregnant after discontinuation delivered full-term live infants. 4.4% had a spontaneous abortion. Women who discontinued the implant system to conceive were less likely to opt for an induced abortion than those who discontinued for irregular bleeding and other reasons (5.9% vs. 36.4-41.6%), suggesting that many women did not want another child and need to be counseled about adopting and offered another contraceptive method. The spontaneous abortion rates for women who discontinued for irregular bleeding and other reasons were 1.7% and 2.7%. No group of former Norplant II users suffered a spontaneous abortion rate greater than the pre-Norplant II use rate (3.6%). These findings show that the Norplant-II implant system does not delay return to fertility in women who stop using it to become pregnant.

Randomized clinical trial with intrauterine devices (levonorgestrel intrauterine device (LNG), CuT 380Ag, CuT 220C and CuT 200B). A 36-month study. Indian Council of Medical Research Task Force on IUD.

A total of 1905 subjects were randomly allocated to four types of intrauterine devices (IUDs) and were observed for 45,683 woman-months of use. While no method failure was observed with levonorgestrel (LNG) IUD, 11 women became pregnant with other devices; 4 with Copper T 380Ag, 1 with Copper T 220C, and 6 while using Copper T 200B, indicating method failure rates of 1.0, 0.3 and 1.6, respectively, at 36 months of use. These rates were within acceptable range. Continuation rates were significantly lower with LNG IUD (74.5, 58.7, 38.8 at 1 year, 2 years and 3 years, respectively) as compared to other copper devices, which ranged between 82.4 to 84.4 at 1 year, 66.6 to 69.9 at 2 years and 45.4 to 50.4 at 3 years. The difference in continuation rates was mainly due to menstrual disturbances (e.g. amenorrhoea, irregular bleeding) which were higher with LNG IUD (27.9 per 100 users) as compared to the copper devices (13.4-15.4 per 100 users) at 36 months of use. The risk of expulsion ranged between 8.3 to 10.6 per 100 users and was comparable for all the devices. The observations from the present study based on 36 months of experience with different intrauterine devices do not indicate the need to replace CuT 200, the device currently in use in the National Programme.

Phase III-clinical trial with Norplant-2 (covered rods). Report of a 24-month study. National Programme of Research in Human Reproduction. Division of Human Resource Development Research Indian Council of Medical Research Ansari Nagar, New Delhi, India.

In a phase III multicentre clinical trial, the subdermal implant NorplantR-2 was studied for its clinical use effectiveness, safety and bleeding pattern. A total of 1466 healthy volunteers, with no contraindication to steroid use, were observed for 29,669 woman-months of use. One method failure was reported at 18 months of NorplantR-2 use. The method was associated with altered menstrual pattern with a trend towards reduced blood loss. The continuation rates were 88.1 and 73.5 per 100 users at 12 and 24 months of use, respectively. Menstrual disturbance, mainly prolonged bleeding, accounted for the majority of the discontinuations. Removal of NorplantR-2 due to local infection was rare (0.4 per 100 users at 24 months). In similar clinical trial conditions, the continuation rate with NorplantR-2 is significantly higher than those observed with LNG IUD and injectable contraceptives, norethisterone oenanthate 200 mg given every 60 +/- 5 days, and is comparable to that of CuT 200 IUD.