A prospective cohort study, with 345 women requiring complete progesterone
replacement for a donor egg cycle, was used to compare Crinone 8% (90 mg pr
ogesterone vaginal gel) twice or once daily versus i.m. progesterone (100 m
g), for endometrial development and pregnancy support. Endometrial histolog
y, serum progesterone levels, pregnancy rates, implantation rates, and blee
ding patterns were used as outcome measures. Mean serum progesterone concen
trations on day 26 were 19.0 + 2.3 ng/ml for twice and 11.3 +/- 6.5 ng/ml f
or once daily Crinone, versus 65.2 +/- 12.5 ng/ml in the i.m. progesterone
group. Endometrial histology was 'in phase' for all women in the Crinone gr
oups and most of the i.m. group. Though eight of 42 patients on once daily
Crinone had serum progesterone levels under 6 ng/ml, there was no correlati
on with endometrial development. Only one patient bled on once daily Crinon
e before the 14th day of progesterone therapy, and she went on to deliver t
wins. Clinical pregnancy, ongoing pregnancy, implantation, and miscarriage
rates were not statistically different among any of the treatment groups. C
rinone 8% administered once or twice daily appears to produce the same endo
metrial development and pregnancy rates as i.m. progesterone in women requi
ring complete progesterone replacement, and without early bleeding.