Comparative Effect of Nigella Sativa+ Black Pepper and Letrozole + Tamoxifen on Female Infertility in Women with Polycystic Ovarian Syndrome: A Randomized Clinical Trial

Background: Polycystic ovary syndrome (PCOS), one of the most common reasons for infertility in terms of anovulation, influences 4–7% of reproductive women. Objectives: This study aimed to compare the impact of Nigella sativa + black pepper with Letrozole + Tamoxifen as a treatment for infertile women with PCOS. Methods: 90 PCOS infertile women aged 18 and 42 who were sent to an infertility clinic took part in this randomized, double-blind and clinical experiment. Patients were split into intervention and control groups at random. Letrozole and Tamoxifen were utilized in the control group. In contrast, Nigella sativa and black pepper were employed in the intervention group (from the third to the seventh day of the menstrual cycle). Throughout therapy, transvaginal ultrasound measures such as ovarian follicular size, number, and endometrial thickness were monitored, and the medication regimen was maintained according to these characteristics. Results: In the intervention and control groups, the pregnancy rate was 22 (48.8%) and 5(11.1%), respectively (p=0.021). On day 12 of the menstrual cycle, there was a significant difference between the two groups endometrial thickness, dominant follicle size, and the number of follicles (p< 0.05). The incidence of Ovarian Hyperstimulation Syndrome (OHSS) did not significantly vary between the two groups (p> 0.05). Conclusion: Increased pregnancy rates are finally brought on by the favorable effects of Nigella sativa and black pepper on the size of dominant follicle and endometrial thickness. Consequently, despite the necessity for standardization by the applied research laboratory of medicinal plants and further clinical trial research, we advise using this low-cost, low-side-effect regimen to treat infertile PCOS patients.