Abstract
Second line of treatment in women with Clomiphene(CC) failure in unexplained infertility is gonadotropins(Gn) which are associated with complications & higher treatment cost. The objective of the present study was to compare the efficacy of letrozole, letrozole gonadotropin and only gonadotropins in women with failed CC and CC-Gn cycles undergoing IUI. Randomized prospective study between 7/2009 and 12/2010. Women with unexplained infertility(n = 261) and CC failure undergoing IUI were randomized into 3 treatment groups. Women in Group A(n = 87cycles = 220) received letrozole(5mg/day from day3-7), Group B (n = 87cycles = 221) received letrozole(5mg/day from day3-7) plus u-FSH 75IU from day7 onwards & Group C(n = 87cycles = 211) received continuous u-FSH 75IU from day3 onwards until hCG injection. The number of follicles, days of stimulation, dose of gonadotropins, endometrial thickness (ET), pregnancy rate per completed cycle, cancellation rates, multiple pregnancy & miscarriage rate were compared between the groups. The pregnancy rate is comparable between letrozole(9.09%) and FSH(13.2%) while lower in letrozole –FSH combination(4.6%). Letrozole- FSH treated cycles had the shortest follicular phase(10 ± 0.9) vs12 ± 0.8 with FSH & 12 ± 0.8 with only letrozole with comparable number of dominant follicles. ET in FSH cycles(10.1 ± 0.8) was significantly higher in comparison to GrA(8.5 ± 0.7) and GrB(7.8 ± 0.4;P<.0001). IUI cancellation rate was least in letrozole(5%) while Group B and Group C had a cancellation rate of 14.09% and 10.4% respectively. Letrozole- FSH protocol is associated with higher cancellation & lower pregnancy rates. A shorter follicular phase by the synergistic action of letrozole & exogenous gonadotropins probably leads to a lower ET and follicular-endometrial dyssynchrony at the time of hCG administration leading to lower pregnancy rates. Letrozole alone appears to be a cost-effective alternative to gonadotropins for patients with unexplained infertility in CC failure.
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