Aim: Aim of the study was to evaluate the effects of 24 weeks administration of myo-inositol plus folic acid (Inofert ®) on clinical, endocrine and metabolic parameters of polycystic ovary syndrome (PCOS) patients.
Methods: Seventy women, 18 to 35 years, were enrolled; 35 patients were enrolled as study group and treated with Inofert ® (200 µg folic acid plus myo-inositol 2 g per day) for 24 weeks. The other 35 patients, similar at baseline to patients in the study group, were enrolled as control group and received no treatment. In all patients the restoration of ovulation and variations of the endocrine and metabolic profile after treatment were assessed.
Results: After 24 weeks, only five of 35 patients treated with Inofert® and 14 of 35 patients in the control group remained anovulatory and this difference was statistically significant. Body mass index decreased significantly in the study group, while a non-significant increasing was recorded in the control group. Moreover, non-significant reduction in circulating levels of LDL, and a statistically significant increase in the levels of HDL in the study group were observed.
Conclusion: Treatment with Inofert® allows to restore rapidly spontaneous ovulation in amenorrheic patients with PCOS and shows a significant advantage in terms of reduction in BMI and a positive trend in terms of changes in serum lipid profile.