Comparing Ovulation Outcomes of Letrozole-Tamoxifen-Estradiolwith and without Vitamin E in Infertile Women with PolycysticOvary Syndrome: A Double-Blind, Randomized Clinical Trial

نویسندگان

1 Departments of Obstetrics and Gynecology, Jahrom University of Medical Sciences, Jahrom, Iran

2 Department of Public Health, Torbat Jam Faculty of Medical Sciences, Torbat Jam, Iran

3 Department of Public Health, Khomein University of Medical Sciences, Khomein, Iran

4 Student Research Committee, Jahrom University of Medical Sciences, Jahrom, Iran

doi
10.22074/ijfs.2025.2055868.1841
چکیده

Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of anovulatoryinfertility. This study evaluated whether adding vitamin E to a regimen of letrozole, tamoxifen, and estradiol improvesovulation outcomes in infertile women with PCOS.Materials and Methods: In a double-blind, randomized clinical trial conducted in Jahrom, Iran (December 2023-August2024), 90 infertile women with PCOS were randomly assigned to two groups. Group A (n=45) received letrozole,tamoxifen, estradiol, and vitamin E, while group B (n=45) received the same regimen without vitamin E. The primaryoutcome was pregnancy rate; secondary outcomes included follicle size, count, and endometrial thickness, measuredon cycle days 3, 7, and 12. Data were analyzed using Chi-square, Fisher’s exact, and t tests (Stata 14).Results: Baseline characteristics including age (mean: 31.21 ± 6.31 Y), BMI (24.96 ± 3.45 kg/m²), and infertilityduration (3.48 ± 2.70 Y) were similar between groups (P>0.05). On day 7, the vitamin E group showed significantlylarger follicles (14.15 ± 0.36 mm vs. 10.90 ± 0.68 mm), more follicles (5.16 ± 0.36 vs. 3.73 ± 0.83), and thicker endometrium(7.16 ± 0.36 mm vs. 5.16 ± 0.36 mm). These advantages persisted on day 12, including improved follicularmaturity and endometrial thickness. Although the pregnancy rate was higher in the vitamin E group (11.1% vs. 6.7%),the difference was not statistically significant (P=0.457). Adverse effects, including ovarian hyperstimulation syndrome(OHSS) and irregular bleeding, did not differ significantly (P=0.553).Conclusion: The results indicate that the addition of vitamin E to the letrozole–tamoxifen–estradiol protocol mightbe associated with improved ovulatory outcomes in women with PCOS. Nevertheless, no significant effect on pregnancyrates was observed. These findings highlight the potential adjunctive role of vitamin E in ovulation inductionamong women with PCOS, although further large-scale randomized trials are needed to confirm its clinical relevance(number registration: IRCT20150407021653N20).