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Efficacy of Letrozole in Comparison with Clomiphene Citrate for Induction of Ovulation in Polycystic Ovary Syndrome with Infertility

Agulebe Chiahemba Joseph1*, Nombur Isaac Lahaga2, Abu Paulinus Oshiotse2, Omoregie Irowa2

Background: Polycystic Ovary Syndrome (PCOS) is a complex metabolic disorder affecting 5 to 10% of women of reproductive age group, with key features including; menstrual cycle disturbance, obesity, hyperandrogenism and the commonest cause of an ovulatory infertility. An effective, simple and safe treatment of PCOS is an important public health initiative with the recent introduction of letrozole as against the traditional use of Clomiphene citrate for ovulation induction in affected patients. Objective: The objective of this study was to compare the efficacy and safety of letrozole in the induction of ovulation in infertile an ovulatory PCOS patients in comparison with clomiphene citrate.

Methodology: One hundred and forty-two infertile patients aged 18 to 40 years that met the inclusion criteria for infertile an ovulatory PCOS were recruited and randomized by computer-based techniques to receive letrozole 5mg or clomiphene citrate 100mg on day 2 to day 6 of menstruation respectively. Data was analyzed using Statistical Package for Social Sciences (SPSS) version 25. Chi-square and Fisher’s exact tests were used to compare qualitative variables and the Student-t test to compare the qualities of the two treatment groups where necessary with p <0.05 considered significant statistical association. The research was approved by the Research Ethics Committee of the Federal Medical Centre, Makurdi and all participants gave written informed consent.

Results: Women in both groups were similar with respect to demographic characteristics at randomization. Following treatment, ovulation (p value=0.001), mean endometrial thickness at midcycle of menstruation (p value=0.000) and pregnancy rate (p value=0.019) occurred significantly more often in patients treated with letrozole than did in the clomiphene citrate group. However in a general perspective, Letrozole and clomiphene citrate were effective. No significant differences were observed with adverse effect between the letrozole and clomiphene citrate treatment groups (p value=0.118). However, there were more hot flushes and dizziness with patients treated with CC in comparison with letrozole.

Conclusion: Letrozole improved ovulation, endometrial thickness and pregnancy rates in patients with an ovulatory infertility PCOS without significant adverse effects when compared to treatment with clomiphene citrate. Therefore, Letrozole could replace CC as the first line medication for ovulation induction in infertile patients with PCOS especially where cost implications or other logistic challenges associated with its sourcing are non-restrictive.