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Background: Ovarian stimulation (OS) for poor ovarian response (POR) patients is still a major challenge in assisted reproductive techniques. Aromatase inhibitors as co-treatment in antagonist protocol are suggested to these patients, but there are controversial reports. Objective: To evaluate the effectiveness Letrozole (LZ) as adjuvant treatment in gonadotropin-releasing hormone (GnRH)-antagonist protocol in POR patients undergoing in vitro fertilization/intracytoplasmic sperm injection cycles. Materials and Methods: This double-blind randomized clinical trial was conducted in Arash women’s hospital. One hundred sixty infertile women with POR based on Bologna criteria were allocated into two groups randomly: LZ + GnRH-antagonist (LA) and placebo + GnRH-antagonist (PA) groups. In the experimental group, the patients received 5 mg LZ on the first five days of OS with 150 IU of recombinant human follicle-stimulating hormone (rFSH) and 150 IU of human menopausal gonadotropin (HMG). The cycle outcomes were compared between groups. Results: The total number of retrieved oocytes and the metaphase II oocytes in LA-treated group were significantly higher than those in the control group (p = 0.008, p = 0.002). The dosage of hMG used and the duration of OS and antagonist administration in LZ-treated group were significantly lower than those of the control group. The number of patients with no oocyte, in the control group, was higher than the LZ-treated group, and the clinical pregnancy rate in LA-treated group (25%) was higher than the control group (18%); however, the differences were not significant statistically. Conclusion: Adding 5 mg of LZ to rFSH/hMG antagonist protocol may improve the in vitro fertilization/intracytoplasmic sperm injection cycle outcome in POR patients. Key words: Letrozole, Ovarian reserve, Primary ovarian insufficiency, Ovulation induction, Fertilization in vitro, Aromatase inhibitors.

Letrozole as co-treatment agent in ovarian stimulation antagonist protocol in poor responders: A double-blind randomized clinical trial