Abstract

Background: Polycystic ovarian syndrome is the most common cause of ovulatory infertility and letrozole and clomiphene are the most common drugs used for in the treatment of the same.

Aim: To compare the efficacy of novel step-up letrozole protocol versus conventional dosage for ovulation induction (OI) in women with polycystic ovary syndrome (PCOS). Methodology: It was prospective non-randomized study including 50 women who underwent 172 treatment cycles with OI and timed intercourse (TI). The study group included 25 women (80 cycles) who received letrozole in a step-up protocol consisting of one, two, three, and four tablets of letrozole (2.5 mg) daily on menstrual cycle days 2, 3, 4, 5 and 6, respectively. The control group of 25 women (92 cycles) received the conventional dose of 5 mg letrozole per day in two divided doses for 5 days starting on menstrual cycle day 2. The primary outcome was clinical pregnancy rate and the secondary outcome was ovulation rate, number of mature follicles, endometrial thickness (ET) and time to reach a dominant follicle.

Results: The two groups were similar in the demographic features and baseline hormonal milieu. There was no significant difference between the two groups with regard to number of mature follicles and ET on Human chorionic gonadotropin (hCG) day (9.1 � 0.22 mm vs. 9.0 � 0.69 mm, p = 0.21). Step-up letrozole protocol resulted in significantly higher ovulation rate (88.7% vs. 71.7%, p < 0.01) and trend towards improvement in clinical pregnancy rate (22.5% vs. 14.1%, p = 0.15).

Conclusion: Letrozole in gradually increased dose achieves better ovulation and higher clinical pregnancy rates as compared with the conventional dose of letrozole. Therefore, it can be used as a first-line treatment for OI in women with PCOS.