A randomized controlled trial comparing combination of letrozole and clomiphene citrate or letrozole alone for ovarian stimulation in infertile women.

Introduction: Infertility is defined by failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. Unexplained infertility was often treated with superovulation by using clomiphene, letrozole, or gonadotropins in a stepwise approach, combined with intrauterine insemination (IUI) (e.g. CC/IUI/, letrozole/IUI, and FSH/IUI) followed by ART. Combination of letrozole and clomiphene have been studied in past but there are fewer studies in Indian scenario. Aims and Objectives: The aim of the present study was to compare the combination of Letrozole and Clomiphene citrate (CC) or Letrozole alone for ovarian stimulation in infertile women. Materials and Methods: In an Open label prospective randomized control study, Total 180 women (90 women as cases and 90 as controls) were included in this study. All Patients were evaluated based on history, general physical examination, clinical examination, and relevant investigations. Study participants were divided into two groups; Group 1 received combination of Letrozole and CC, while Group 2 received Letrozole alone. All the women were followed till next menses or pregnancy. Results: More than three follicles ruptured in 11.1% and 2.2% in Group 1 and 2, respectively. 1-2 Follicle rupture in Group 1 was 46.7% and in Group 2 was 73.3%. Conception in group 1 was 3.3 percent as compared to 2.2 percent in group 2. In group 1, 7.8% women had hot flushes, 6.7% had nausea and 1.1% had ovarian hyperstimulation syndrome (OHSS). In group 2, 4.4% women had hot flushes, 6.7% had nausea and none of them had OHSS. Conclusion: It was concluded that both the regimes i.e. combination of CC plus Letrozole and Letrozole-alone were equally efficacious and safe to use in the treatment of female infertility with Letrozole-alone regime being slightly more effective in terms of endometrial thickness at trigger.