There is concern that male fertility is declining, but this is difficult to
study because few men volunteer for studies of semen quality, and recruitm
ent bias may over-represent the subfertile, The Human Reproduction Programm
e of the World Health Organization developed a protocol for multicentre stu
dies of fertility involving a questionnaire for pregnant women to obtain ti
me to pregnancy (TTP): the number of menstrual cycles taken to conceive. Ma
le characteristics and semen quality will be determined in a subset of the
partners, Our aim was to validate the TTP questionnaire, and to examine pot
ential recruitment bias and feasibility of conducting large-scale surveilla
nce of fertility, The questionnaire was administered to 120 pregnant women
(16-32 weeks). Validation included internal reliability by consistency of r
esponses, test-re-test reliability by repeat administration (20 women) and
accuracy by comparison of gestational age from first antenatal ultrasound a
nd menstrual dates. Internal reliability was high, Agreement between catego
rical responses on re-testing was very good (k > 0.8). In both the re-test
and gestational age analysis, differences in TTP of 1 cycle were found (sta
ndard deviation <0.25 cycles), In this small pilot study there was no evide
nce of recruitment bias, Response rates indicate the feasibility of surveil
lance of fertility in large maternity centres.