OBJECTIVE: To determine the effectiveness of an electronic hormonal fertility monitor plus cervical mucus monitoring to avoid pregnancy. DESIGN: A 12-month prospective clinical efficacy trial. SETTING AND PARTICIPANTS: One hundred ninety five (195) women (mean age 29.8 years) seeking to avoid pregnancy with a natural method at 5 clinical sites in 4 cities. INTERVENTION: Each participant was taught to track fertility by self-observation of cervical mucus and an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone. MAIN OUTCOME MEASURES: Correct- and typical-use unintended pregnancy rates. RESULTS: There were a total of 26 unintended pregnancies, 3 with correct use. With 1,795 months of use, the correct-use pregnancy rate was 2.1% per 12 months of use (i.e., 97.9% effective in avoiding pregnancy when rules of the method were always followed) and the imperfect-use pregnancy rate was 14.2% per 12 months of use (i.e., 85.8% effective in avoiding pregnancy when rules of the method were not always followed and all unintended pregnancies and months of use were included in the calculations). CONCLUSIONS: Correct use of an electronic hormonal fertility monitor with cervical mucus observations can be as effective as other fertility awareness-based methods of natural family planning. Comparative studies are needed to confirm this conclusion.
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