K. Jobanputra et al., Crinone 8% (90 mg)* given once daily for progesterone replacement therapy in donor egg cycles, FERT STERIL, 72(6), 1999, pp. 980-984
Objective: To determine whether once-daily dosing of Crinone 8% (90-mg prog
esterone vaginal gel; Serono Laboratories, Inc., Norwell, MA) is sufficient
for normal endometrial development and pregnancy support.
Design: Prospective cohort study.
Setting: Academic medical center.
Patient(s): Eighty-six women who required complete progesterone replacement
for a donor egg cycle.
Intervention(s): Crinone 8% (90 mg) once daily or IM progesterone (100 mg)
once daily was administered from day 15 onward. Both groups underwent an en
dometrial biopsy on day 26 of a mock cycle, followed by a second cycle in w
hich ET was performed.
Main Outcome Measure(s): Endometrial development, serum progesterone levels
, pregnancy rates, implantation rates, and bleeding patterns.
Result(s): Mean (+/-SD) serum progesterone levels on day 26 were 11.3 +/- 6
.5 ng/mL in the Crinone group and 65.2 +/- 12.5 nglmL in the IM progesteron
e group. At histologic examination, endometrial biopsy specimens were found
to be "in phase" for 100% (42/42) of women in the Crinone group and 95.5%
(42/44) of women in the IM progesterone group. Although 8 of 42 patients ha
d serum progesterone levels of <6 ng/mL, there was no correlation with endo
metrial development. Only 1 patient bled before the 14th day of progesteron
e therapy, and she went on to be delivered of twins. Clinical pregnancy, on
going pregnancy, implantation, and miscarriage rates were not statistically
different for the Crinone and IM progesterone groups: 45.6% (21/46) versus
52.3% (23/44); 39.1% (18/46) versus 40.9% (18/44); 21.5% (34/158) versus 1
9% (30/158), and 14.3% (3/21) versus 22% (5/23), respectively. Power was su
fficient to detect a 25% difference in clinical pregnancy rates.
Conclusion(s): Crinone 8% administered once daily appears to produce the sa
me endometrial development and pregnancy rates as IM progesterone in women
who require complete progesterone replacement, and it does not cause early
bleeding. ((C)1999 by American Society for Reproductive Medicine.).