Comparing Ovulation Outcomes of Letrozole-Tamoxifen-Estradiolwith and without Vitamin E in Infertile Women with PolycysticOvary Syndrome: A Double-Blind, Randomized Clinical Trial
Abstract
Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of anovulatory infertility. This study evaluated whether adding vitamin E to a regimen of letrozole, tamoxifen, and estradiol improves ovulation outcomes in infertile women with PCOS.
Materials and methods: In a double-blind, randomized clinical trial conducted in Jahrom, Iran (December 2023-August 2024), 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 primary outcome was pregnancy rate; secondary outcomes included follicle size, count, and endometrial thickness, measured on 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 infertility duration (3.48 ± 2.70 Y) were similar between groups (P>0.05). On day 7, the vitamin E group showed significantly larger 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 follicular maturity 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.
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