The Effect of Myo-Inositol and Folic Acid (Inofolic) Supplementation on Fertility Outcomes in Infertile Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial

Polycystic ovary syndrome (PCOS) is a leading endocrine cause of anovulatory infertility. Insulin resistance is a key pathogenetic factor, and while metformin is a common treatment, alternative therapies like inositols are being explored. This study investigated the efficacy of Inofolic® (a combination of myo-inositol and folic acid) as an adjunct to standard treatment on fertility outcomes in infertile women with PCOS. In this randomized controlled trial, 100 infertile women with PCOS were allocated to either a control group (n=50) receiving standard treatment (metformin and cyclical progesterone) or an intervention group (n=50) receiving standard treatment plus Inofolic powder (2 sachets/day, 2000 mg myo-inositol and 200 mcg folic acid each) for three months. Primary outcomes were follicular development (size and count measured via serial transvaginal ultrasonography) and fertility rate (serum β-hCG positivity). Secondary outcomes included hormonal (FSH, LH, prolactin) and metabolic (blood glucose) parameters. The intervention group demonstrated a significantly greater increase in follicular size and a more favorable trajectory in follicular count over the three-month period compared to the control group (p < 0.001). While β-hCG positivity rates increased significantly over time in both groups, the final rates at the end of the study were not statistically different (22.9% in control vs. 24% in intervention, p > 0.05). No significant intergroup differences were observed in secondary hormonal or metabolic outcomes. Adjunctive Inofolic supplementation significantly improved follicular development indices in women with PCOS. However, it did not lead to a significantly higher pregnancy rate within the three-month study period compared to standard treatment alone, suggesting its primary benefit may be on optimizing folliculogenesis rather than immediate conception.