Objectives: This study aimed to evaluate the ovulatory outcome of combined clomiphene citrate (CC) stimulation with pioglitazone hydrochloride (ACTOS) versus metformin treatment in conjunction with weight reduction dieting program.
Patients & Methods: The study included 80 women; 52 were primary and 28 were secondary infertile with mean age of 28.1±3.1 years. All PCOS patients were diagnosed according to the Rotterdam criteria and underwent transvaginal ultrasonography (TVU), anthropometric measurements and estimation of fasting blood glucose (FBG), plasma insulin (FPI) and insulin resistance (IR) was measured by homeostasis model assessment (HOMA). Hormonal profile including FSH, LH, estradiol and progesterone was evaluated. CC (50 mg twice daily) was given on Days 2–6 of a menstrual period or after a progestogen withdrawal bleed in combination with either ACTOS oral 15 mg tablets once daily or metformin oral 0.5 gm tablets trice daily. Ovulation was monitored by measuring the serum concentration of progesterone on Day 21 of the menstrual cycle; a serum progesterone level of ≥14 nmol/l indicates ovulation that was assured using TVU for evident ovulation with a dominant follicle size >16 mm and the frequency of women got these follicles was considered as ovulation success rate. At the end of 3 months, HOMA-IR score was evaluated as an index for the impact of the study drugs on insulin resistance.
Results: At the end of 3-months therapy, all studied women showed significant reduction of BMI with the percentage of change of HOMA-IR score was significantly higher (F=28.404, p=0.035) with ACTOS compared to that reported with metformin. Ovulation was induced and assured in 65 patients (81.3%); 36 patients (90%) received ACTOS and 29 patients (72.5%) received metformin with significantly higher levels with ACOTS compared to metformin. Using ROC curve analysis to predict the oncoming effect of insulin sensitizing drugs on ovulatory function defined the pre-treatment HOMA-IR score as a significant screening parameter irrespective of the BMI or its constituents or the patient's age.
Conclusion, for PCOS women, combined CC and ACTOS therapy in association with increased daily physical activity and weight reduction provides the best chance for getting regular ovulation with better biomilieu and promises for higher chances for getting pregnant
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