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  1. 1

    Psychosexual aspects of natural family planning as revealed in the World Health Organization multicenter trial of the ovulation method and the New Zealand Continuation Study.

    France MM

    In: Natural family planning: current knowledge and new strategies for the 1990s. Proceedings of a conference, Part II, Georgetown University, Washington, DC, December 10-14, 1990, edited by John T. Queenan, Victoria H. Jennings, Jeffrey M. Spieler, Helena von Hertzen. Washington, D.C., Georgetown University, Institute for International Studies in Natural Family Planning, [1991]. 118-20.

    Successful natural family planning (NFP) use depends upon the day-to-day sexual decision making of users. Given the important role of psychosexual factors in this decision making, they are an important influence in both the effectiveness of natural methods as well as in their acceptability as a means of family planning. The World Health Organization (WHO) Multicenter Study of the ovulation method was conducted in Auckland, New Zealand; Bangalore, India; Dublin, Ireland; Manila, the Philippines; and San Miguel, El Salvador with the secondary objective of obtaining psychosexual information to identify factors leading to the successful use of NFP. Findings were reported in 1987. This paper reviews some of the WHO findings and compares them with some preliminary findings of the current study in New Zealand on continuation rates of NFP users following the symptothermal method with the goal of determining rates of continuation and reasons for acceptability. The WHO study found that the more satisfied people were with NFP and the less difficulty they reported with abstinence, the more likely they were to be successful users, as measured by their avoidance of pregnancy. The New Zealand Study, however, indicates that for many couples abstinence may not be the main difficulty in using NFP, and that long-term acceptance is not necessarily influenced by pregnancy. The authors notes that the two studies involved different NFP methods. The challenge for the future of NFP services is to learn more about what leads to acceptability in different countries and cultures, remembering that for a natural method of family planning, success depends very much upon the decisions, attitudes, and resulting behavior of the couple involved.
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  2. 2

    Present status of contraceptive vaginal rings.

    Jackson R; Hickling D; Assendorp R; Elstein M

    ADVANCES IN CONTRACEPTION. 1990 Sep; 6(3):169-76.

    Clinical trials of vaginal rings containing progestins or ethinyl estradiol and progestins by WHO, the Population Council and private firms are reviewed. Contraceptive steroids can be formulated into Silastic vaginal rings because they are released continuously from this material (zero-order kinetics). Vaginal rings have the advantage of avoiding the 1st pass effect on the liver, as well as self- administration, unrelated to the timing of coitus and regulation of withdrawal bleeding with removal for 7 days per cycle. The shell vaginal ring, with an inert core, a layer of Silastic containing the progestogen, and an outer Silastic layer is designed to regulate release by the thickness of the outer layer. The WHO tested rings releasing 200 mcg norethisterone/day resulting in too many menstrual side effects; and 50 mcg/day with too high a failure rate. A ring releasing 20 mcg levonorgestrel is expected to perform well. The Population Council designed rings releasing 152 mcg ethinyl estradiol and 252 mcg levonorgestrel, and 183 mcg ethinyl estradiol and 293 mcg levonorgestrel. These resulted in pregnancy rates of 2/100 woman years, and continuation rates of 50%, but unacceptably adverse lipid effects. Women discontinued for vaginal symptoms. Compared to a similar combined oral pill, the rings offered no advantage. WHO subsequently introduced a ring releasing 20 mcg levonorgestrel: efficacy was 3.8 and continuation over 50%. A new segmented ring with desogestrel is causing fewer androgenic effects and bleeding complaints. Another ring in current trials gives off 120 mcg desogestrel and 30 mcg ethinyl estradiol with no pregnancies and good acceptability in 100 women to date. Availability of Silastic material and quality control in manufacture are seen as obstacles to overcome for mass production of these vaginal rings.
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  3. 3
    Peer Reviewed

    Clinical trials of the ovulation method.

    Benagiano G; Bastianelli C


    In 1975, World Health Organization (WHO) Special Program of Research, Development, and Research Training in Human Reproduction carried out a multicenter, cross-cultural evaluation of the ovulation method in 5 countries--El Salvador, India, Ireland, New Zealand, and the Philippines. Clinical studies were also conducted by others. The WHO trial involved 869 women. More than 10% were illiterate; more than 20% had a technical or university education. The study was planned so that a woman's ability to calculate fertile days could be evaluated. The trial was divided into a learning phase of 3 months (extended to 6 for slow learners) and a 13-cycle effectiveness phase. In 3 months, more than 93% of the women learned to recognize their mucus pattern; only 1.3% failed. Self-recognition of mucus changes was learned equally well regardless of education. 45 pregnancies occurred in this phase. 725 women entered the effectiveness phase. In general, the method was well accepted. 130 pregnancies occurred during the effectiveness phase. 121 of these (almost 70%) were caused by conscious departures from the method; only 17 were truly method-related (less than 10%). An overall Pearl rate (per 1300 cycles) was 22.3. It was only 2.2% for method-related failures. As for pregnancy outcomes, live births accounted for 85.9% of the total. Where the child's sex was known, the proportion of males was .58 (81 males; 59 females). It was .61% when coitus occurred 2-5 days before the peak day (PD) and .67 among coitus occurring 2-4 days after PD. The proportion of males among those conceived within 1 day of PD was .55. This does not differ from the typical population value of .51. The WHO study does not support the hypothesis of an increased risk of malformations and spontaneous abortions in women practicing natural family planning (NFP). Partners were less satisfied with the method than women. However, more than 1/2 found no difficulty with abstinence. This indicates proper selection; not a true acceptance rate. The major drawback of NFP seems to be conscious rule breaking. 3 additional trials of the ovulation method were undertaken--1 in Tonga; a multicenter US study; and a Los Angeles study. These trials confirmed the main features of the method.
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  4. 4

    Long-acting systemic contraceptives.


    In: Diczfalusy, E., ed. Regulation of human fertility. (Proceedings of the WHO Symposium on Advances in Fertility Regulation, Moscow, USSR, November 16-19, 1976) Copenhagan, Denmark, Scriptor, 1977. p. 323-360

    Long-acting systemic contraceptives inhibit fertility either at a central or peripheral level. In some instances, a mixed reaction is likely to be working: during the 1st portion of the drug's life-span the contraceptive effect is exerted at a hypothalamic central level, whereas later on--when ovulation is restored--the action is on the cervix or uterus. The most important factor holding back utilization of long-acting agents is serious interference with regularity of the menstrual cycle, and delivery systems must be devised with zero-order release rates to improve cycle control and acceptability. Monthly injectables consisting of synthetic progestins alone proved unsuitable for contraception because of frequent and prolonged amenorrhea. Addition of an estrogenic substance helped cycle control, and a dihydroxyprogesterone acetophenide plus estradiol enanthate combination seems most worthy of clinical investigation; so far, 15,000 woman-months of experience have yielded no unwanted pregnancies. Few bleeding pattern irregularities were reported, but premenstrual tension, dysmenorrhea, and libido changes occurred. Reversibility of drug-induced anovulation has been shown by spontaneous ovulation resumption 12-42 weeks after cessation. Tri-monthly injections of Depo Provera resulted in pregnancy rates averaging .5/100 woman-years of use. Biannual injectable and sustained release systems are discussed and data are presented.
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