Compliance with short-term high-dose ethinyl oestradiol in young patients with primary infertility. New insights from the use of electronic devices.

The objective of the study was to investigate patient compliance with ethinyl oestradiol therapy. Medication was prescribed to be taken in 20-micrograms doses four times daily for seven days. Oestrogens are prescribed for standardization of the cervical mucus before the sperm cervical-mucus penetration test (SCMPT) is performed. Relation of drug compliance with adverse drug reactions reported by the patients. The methodology used in this study was continual microprocessor-based monitoring by means of the Medication Event Monitoring System, MEMSTM. Adverse drug reactions were recorded by means of standardized interviews. Investigations were carried out on thirty female patients, mean age: 28.8 years (range 21 to 36 years), with primary infertility, mean duration of infertility: 3.9 years (range 9 months to 8 years). The results showed that individual patients' compliance was remarkably variable, ranging from 14.3% up to 136%. The average compliance was 65%. Less than 30% of the prescribed doses were taken on schedule. Administration of oestrogens was effective in all but one patient. High cervical indices were documented irrespectively of the dose taken. In answer to the questionnaire, 24 out of 30 women reported side effects, of which 79% were rated by the patients as being mild. The lower the drug compliance was, the more adverse reactions were reported. In patients who took more than 65% of the drug, this inverse relationship was statistically significant (r = -0.71, p = less than 0.01). Our conclusion is that the empirically fixed daily dose of 80 micrograms of ethinyl oestradiol for seven days appeared to be too high in regard of the observed dose response, i.e. cervical mucus quality. A dose finding study, including compliance monitoring, seems to be reasonable. Within further studies, a simpler dosage regimen should also be taken into account. The observed association between patients' reports of adverse effects and drug compliance deserves further investigation.