The effect of clomiphene citrate, herbal mixture, and herbal mixture along with clomiphene citrate on clinical and para-clinical parameters in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial.

Introduction: To evaluate the effect of a herbal mixture (i.e., ) alone and in combination with clomiphene citrate (CC) compared to CC on the treatment of polycystic ovary syndrome (PCOS).

Material And Methods: This single-blind randomized clinical trial was conducted on 60 infertile participants with PCOS who were randomly divided into three groups. After spontaneous or progestin-induced withdrawal bleeding, group 1 ( = 20) received routine treatment with CC (50-150 mg) for three menstrual cycles from the 3 to 5 day of menstruation for 5 days while group 2 ( = 20) and group 3 (n = 20) received herbal mixture capsules 700 mg/day and the herbal mixture along with CC for 3 months, respectively. Finally, several related parameters were measured, including the level of sex steroids, homeostatic model assessment for insulin resistance (HOMA-IR), lipid profile (primary outcomes), thyroid hormones, and clinical features. The analysis was based on intention-to-treat analysis.

Results: No statistically significant differences were observed between the groups in terms of socio-demographic characteristics. However, after adjustment for baseline, luteinizing hormone (aMD = 4.9; 95% CI: 3.7-6.2), luteinizing hormone/follicle-stimulating hormone (aMD = 0.9; 95% CI: 0.7-1.2), total testosterone (aMD = -0.12; 95% CI: -0.2 to -0.01) in group 2 and free testosterone (aMD = -6.0; 95% CI: -9.7 to -2.3) in group 3 revealed a significant difference compared to group 1. In addition, HOMA-IR in group 2 (aMD = -1.3; 95% CI: -2.4 to -0.2) decreased significantly compared to group 1. Further, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol decreased significantly in group 2 (aMD = -21.8; 95% CI: -31.5 to -12.1; aMD = -29.9; 95% CI: -47.9 to -12.0; aMD = -21.2; 95% CI: -31.3 to -11.1; aMD = -5.1; 95% CI: -7.5 to -2.7) and group 3 (aMD = -18.3; 95% CI: -27.4 to -9.2; aMD = -26.9; 95% CI: -43.8 to -9.9; aMD = -21.4; 95% CI: -31.1 to -11.7; aMD = -5.9; 95% CI: -8.3 to -3.6) compared to group 1, respectively. However, high-density lipoproteins cholesterol in group 2 (aMD = 6.8; 95% CI: 2.9-10.7) and group 3 (aMD = 10.7; 95% CI: 7.2-14.7) increased remarkably compared to group 1. Overall, clinical outcomes improved significantly in all groups (p < 0.05).

Conclusions: In general, the herbal mixture along with CC was found to improve free testosterone, HOMA-IR, lipid profile, and clinical features of PCOS women.