This study examined whether the prostaglandin E-1 analogue misoprostol (400
mug), when placed vaginally at the time of intrauterine insemination (IUI)
improves pregnancy rates. A prospective, placebo-controlled, randomized an
d double-blind study involving 274 women in 494 IUI cycles resulted in a to
tal of 64 pregnancies (13 % per cycle). Misoprostol cycles totalled 253, wi
th 43 pregnancies (17% per cycle), whereas placebo cycles totalled 241, wit
h 21 pregnancies (9% per cycle). The cumulative pregnancy rate with misopro
stol treatment was significantly greater than with placebo (P = 0.004, Cox
proportional hazards regression). The benefit of misoprostol was seen in cl
omiphene cycles (14 versus 4%, P = 0.006), and was indicated in FSH cycles
(33 versus 15%, borderline significance) and natural cycles (15.6 versus 7.
7%, not significant), but was not seen in clomiphene/FSH cycles (18.2 versu
s 23.5%, not significant). Misoprostol treatment did not increase pain scor
e on the day of IUI (1.1 versus 1.4) and at 1 day post IUI (0.6 versus 0.8)
. Complications were rare in both groups [six (2%) subject cycles in the mi
soprostol cycles compared with two (1%) in the placebo group], It is conclu
ded that the use of vaginal misoprostol may improve the chance for pregnanc
y in women having IUI in a wide variety of cycle types.