Background: Infertility, defined as the inability to conceive after 12 months of unprotected intercourse in women under 35 years or after 6 months in women aged 35 years or older, affects 8–12% of women worldwide. Clomiphene citrate, a selective estrogen receptor modulator, and letrozole, an aromatase inhibitor, are widely used agents for ovarian stimulation.
Objective: To compare the effectiveness of clomiphene citrate and letrozole in infertile women at Lamis Infertility Center, Misurata, Libya.
Methods: A randomized controlled trial was conducted at Lamis Infertility Center, Misurata, Libya, between January and December 2025. Two hundred infertile women were randomly assigned to receive either clomiphene citrate (n=100) or letrozole (n=100). Clinical data were collected and analyzed to assess treatment outcomes with IBM SPSS v24.
Results: The mean age of participants was 34.2 ± 7.8 years. Primary and secondary infertility were equally represented (50% each), with unexplained infertility accounting for 81% of cases. Ovarian hyperstimulation occurred in 8% overall (10% in the letrozole group vs. 6% in the clomiphene group). Pregnancy was achieved in 86% of cases (172/200), with a significantly higher rate in the letrozole group (94/100, 94%) compared to the clomiphene citrate group (78/100, 78%) (p = 0.021).
Conclusion: Letrozole demonstrated superior pregnancy outcomes compared to clomiphene citrate, although with a slightly increased risk of ovarian hyperstimulation in women with polycystic ovarian syndrome. Age, infertility type, and unexplained infertility influenced treatment response. Letrozole may be considered a preferred option for enhancing pregnancy rates in infertile women.