Abstract
to evaluate the effectiveness of ovarian stimulation with tamoxifen or letrozole compared to standard ovarian stimulation on the number of oocytes retrieved in women with breast cancer in the course of fertility preservation. Multi-center randomized open-label trial in the Netherlands and Belgium. Women between 18 and 43 years with breast cancer who opted for banking of oocytes or embryos in the course of fertility preservation were included. We randomly assigned them to one of the three study groups; group 1 ovarian stimulation plus tamoxifen (60 mg per day), group 2 ovarian stimulation plus letrozole (5 mg per day) or group 3 standard ovarian stimulation without additional medication. Primary outcome was the number of oocytes retrieved at follicle aspiration. Secondary outcomes were number of mature oocytes retrieved, number of oocytes or embryos banked and peak E2 levels during ovarian stimulation. Between January 2014 and December 2018, we randomised 162 women with breast cancer. We analysed the primary outcome for 148 (91%) women of which 142 women (88%) underwent ovum pick up. Mean age of the women was 32 years.51 women underwent ovarian stimulation plus tamoxifen, 51 plus letrozole and 46 standard ovarian stimulation without additional medication. The mean number of oocytes retrieved at follicle aspiration was 12.6 (group 1), versus 14.2 (group 2) versus 13.3 (group 3) (mean difference in number of oocytes: group 1 vs. group 3 -0.675 ;95% CI, -5.6 to 4.3; group 2 vs. group 3 0.871; 95% CI, -4.1 to 5.9). The mean number of oocytes banked was 10.4 (group 1) versus 10.5 (group 2) versus 10.2 (group 3) (mean difference in number of oocytes banked: group 1 vs. group 3 0.243; 95% CI,-4.2 to 4.7; group 2 vs. group 3 0.297; 95% CI, -4.2 to 4.8). Mean number of embryos banked was 5.9 (group 1) versus 4.9 (group 2) versus 5.0 (group 3) (mean difference in number of embryos banked: group 1 vs. group 3 0.857; 95% CI, -3.0 to 4.7; group 2 vs. group 3 -1.33; 95% CI, -4.0 to 3.7). These results show that the addition of tamoxifen or letrozole to standard ovarian stimulation did not effect the number of oocytes or embryos banked in the course of fertility preservation for women with breast cancer. Whether the addition of tamoxifen or letrozole to standard ovarian stimulation affects the long-term follow up in terms of safety in women with breast cancer, remains to be seen.
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