Objective: To compare the incidence of noncompliance measured objectively b
y a home use fertility monitor with the traditional self-reported incidence
of compliance in a study of a new method of contraception.
Design: Prospective cohort study.
Setting: A large fan-Lily planning clinic in Edinburgh.
Patient(s): Thirty-two healthy women who took part in a trial assessing the
efficacy of a novel method of contraception involving accurately timed adm
inistration of a single dose of mifepristone.
Intervention(s): Mifepristone was administered orally and a blood sample wa
s collected on the same day.
Main Outcome Measure(s): Percentage of missed tests detected by the monitor
against the self-reported percentage during the critical period.
Result(s): Women failed to perform 24.2% (95% confidence interval, 16.5-31.
5) of the tests in the 162 cycles analyzed. They missed tests at an absolut
ely vital time for contraceptive efficacy in 42% of cycles according to the
monitor while admitting to missing tests in 14.8%. Poor compliance was ass
ociated with younger women, those who discontinued the study before complet
ion, and cycles in which women were not relying on the contraceptive method
,
Conclusion(s): The use of microelectronic monitoring systems may improve Ou
r understanding of the extent of patient noncompliance, providing objective
information that no other monitoring technique can produce. This understan
ding provides the opportunity to make the optimum use of potentially effect
ive treatments while validating research evidence. (Fertil Steril (R) 2001;
76:1196-1201. (C) 2001 by American Society for Reproductive Medicine.).