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    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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