Abstract

Background: Letrozole is currently considered as first line ovulation induction drug in anovulatory PCOS women. Insulin sensitizers like Metformin have a proven role as an adjuvant to improve ovulatory function in resistant PCOS women. Letrozole and Metformin combined as first line ovulation induction option has not been studied much, neither has been compared to other options. Objective: The aim of this study was to compare Letrozole plus Metformin vs Letrozole alone as first line ovulation induction drug in treatment naive infertile PCOS women. Materials & Methods: 125 PCOS patients with anovulatory infertility were randomized by a computer generated randomization list to receive either Letrozole 5 mg from day 3-7 of menses plus Metformin daily (65 patients,150 cycles, Group I) or Letrozole 5mg/day from day 3-7 (60 patients, 121 cycles, Group II). The primary outcome studied was live birth rates and the secondary outcomes reported were ovulation rate, mono / multifollicular development, endometrial thickness, pregnancy rates, abortion and twinning rates. Results: Live birth rate was 33.8% in group I and 45.8% in group II (p=0.17) which was not statistically significantly different. The ovaluation rate was 85.9% and 86.7% (P=0.85) respectively. Multi follicular ovulation was slightly more in Group 2 (38.6% vs 48.1%). Conclusion: There was no significant benefit of adding Metformin to Letrozole as first line ovulation induction drug in terms of live birth rate or ovulation rates.

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