A Randomized Clinical Trial on Comparing The Cycle Characteristics of Two Different Initiation Days of Letrozole Treatment in Clomiphene Citrate Resistant PCOS Patients in IUI Cycles

BACKGROUND: There are still many questions about the ideal protocol for letrozole (LTZ) as the commonest aromatase inhibitor (AI) used in ovulation induction. The aim of this study is to compare the ultrasonographic and hormonal characteristics of two different initiation times of LTZ in clomiphene citrate (CC) failure patients and to study androgen dynamics during the cycle. MATERIALS AND METHODS: This randomized clinical trial was done from March to November 2010 at the Mashhad IVF Center, a university based IVF center. Seventy infertile polycystic ovarian syndrome (PCOS) patients who were refractory to at least 3 CC treatment cycles were randomly divided into two groups. Group A (n=35) receiving 5 mg LTZ on cycle days 3-7 (CD3), and group B (n=35) receiving the same amount on cycle days 5-9 (CD5). Hormonal profile and ultrasonographic scanning were done on cycle day 3 and three days after completion of LTZ treatment (cycle day 10 or 12). Afterward, 5,000-10,000 IU human chorionic gonadotropin (hCG) was injected if at least one follicle ≥18 mm was seen in ultrasonographic scanning. Intrauterine insemination (IUI) has been done 36-40 hours later. The cycle characteristics, the ovulation and pregnancy rate were compared between two groups. The statistical analysis was done using Fisher’s exact test, t test, logistic regression, and Mann-Whitney U test. RESULTS: There were no significant differences between two groups considering patient characteristics. The ovulation rate (48.6 vs. 32.4% in group A and B, respectively), the endometrial thickness, the number of mature follicles, and length of follicular phase were not significantly different between the two groups. CONCLUSION: LTZ is an effective treatment in CC failure PCOS patients. There are no significant differences regarding ovulation and pregnancy rates between two different protocols of LTZ starting on days 3 and 5 of menstrual cycle (Registration Number: IRCT201307096467N3).