Polycystic ovary syndrome (PCOS) is one of the most prevalent hormonal disorders among women of reproductive age causing irregular menstrual cycles, excessive body or facial hair, miscarriage and infertility. The latter being a most common PCOS symptoms. Because the symptoms are seemingly unrelated to one another, PCOS is often overlooked and undiagnosed. The present study is an open label, one-arm, non-randomized, post-marketing surveillance study in 50 premenopausal women (18-45 years, BMI<42) diagnosed with PCOS using a novel Trigonella foenum-graecum seed extract (fenugreek seed extract, Furocyst, 2 capsules of 500 mg each/day) extract, enriched in approximately 40% furostanolic saponins, over a period of 90 consecutive days. The study was conducted to determine its efficacy on the reduction of ovarian volume and the number of ovarian cysts. Ethical committee approval was obtained for this study. Furocyst treatment caused significant reduction in ovary volume. Approximately 46% of study population showed reduction in cyst size, while 36% of subjects showed complete dissolution of cyst. It is important to mention that 71% of subjects reported the return of regular menstrual cycle on completion of the treatment and 12% of subjects subsequently became pregnant. Overall, 94% of patients benefitted from the regimen. Significant increases in luteinizing hormone (LH) and follicular stimulating hormone (FSH) levels were observed compared to the baseline values. Extensive blood chemistry, hematological and biochemical assays demonstrated the broad-spectrum safety. Furocyst caused significant decrease in both ovarian volume and the number of ovarian cysts. Serum ALT, BUN and CK were assessed to demonstrate the broad-spectrum safety of Furocyst. No significant adverse effects were observed. In summary, Furocyst was efficacious in ameliorating the symptoms of PCOS.

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Study question Does combinations therapy of insulin sensitizing agents, antioxidants and vitamins are safe and efficacious in PCOS patients. Summary answer Combination therapy of inositols, antioxidants and vitamins is safe and effective non-hormonal treatment option to manage PCOS. What is known already Monotherapy of insulin sensitising agents, antioxidants and vitamins is beneficial in the treatment of PCOS. Nutritional supplement containing inositols, N-acetylcysteine (NAC), lycopene, chromium picolinate, vitamin D3, biotin and folic acid treatment resulted in a significant improvement in menstrual cyclicity, acne and hirsutism. But there is no evidence pertaining to the hormonal parameters and ovarian morphology. Therefore, the present investigation was planned to evaluate the effects of combination therapy of inositols, antioxidants and vitamins on sign and symptoms, metabolic and hormonal parameters in women with PCOS. Study design, size, duration Multicentric, retrospective, observational cohort study was planned for the first time at thirty-six fertility clinics in different states of India from April 2019 to November 2020. Both lean and obese patients (16–39 years; n = 180) with confirmed diagnosis of PCOS as per the Rotterdam/ESHRE criteria were included in study. Participants/materials, setting, methods Patients were received a combination therapy of insulin sensitizers, antioxidants and vitamins in a marketed formulation (Trazer F ForteTM) twice daily as a tablet for 3 months and thereafter ovulation induction was done using letrozole (2.5–5 mg). Primary outcomes were improvements in signs of PCOS (menstrual cyclicity or ovulation restoration, acne and hirsutism), body weight, body mass index, waist circumference, ovarian cysts, pregnancy rate and hormonal balance. Secondary outcome was the evaluation of side effects. Main results and the role of chance Combination therapy of Trazer F ForteTM containing insulin sensitising agents (inositols, NAC and chromium), antioxidants (NAC and lycopene), and vitamins (vitamin D, biotin and folic acid) showed significant improvement in menstrual cyclicity by 54.3% and 88.2% in obese PCOS cases, and 48.7% and 79.5% in lean PCOS cases after 3- and 6-month of intervention respectively. Significant improvement was observed in acne, hirsutism and ovarian cysts post-intervention in both obese and lean PCOS women. After successful completion of the treatment, significant corrections were observed in metabolic (fasting glucose, fasting insulin and HOMA-IR) and hormonal profile (free testosterone, LH:FSH ratio, AMH and progesterone) in obese as well as lean PCOS cases. The clinical pregnancy rate was 16.2% and 34.1% in obese women, and 9.9% and 22.1% in lean cases after 3- and 6-month of intervention respectively. Limitations, reasons for caution Prevalent of PCOS is different in different population in India with diverse ethnic background. Hence, community-based intervention studies on larger population are needed to assess the efficacy and safety of such combinations amongst different age groups of women with PCOS. Wider implications of the findings: Since, PCOS is a multifactorial disorder, combined use of inositols, antioxidants and vitamins can be used as a promising and clinically relevant non-hormonal treatment option for the management of PCOS. Trial registration number NA

Polycystic ovarian syndrome (PCOS) currently affects nearly 6-10% of women of reproductive age. A frequent feature of women with PCOS is insulin resistance accompanied by compensatory hyperinsulinemia, and increasing evidence suggests that hyperinsulinemia plays an important role in the pathogenesis of PCOS, pointing the way to new and novel therapy for PCOS. The study was planned with one natural alternative remedy Standardized Fenugreek seeds extract as FurostanolicSaponins and Myo-Inositol.Standardized Fenugreek seeds extract as Furostanolic saponins which contains bioactive components Saponins extracted from Fenugreek seeds improves insulin sensitivity and, in turn, may regulate circulating androgen levels. It improves insulin-mediated glucose disposal in women with PCOS [1,2]. It also decreased theLuteinizing HormoneLH/FSH (Follicle- Stimulating Hormone) ratio as observed in my last study [2-4]. Myo-inositol not only improves fertility by lowering male sex hormones in both, women with and without PCOS but it could also improve ovulation in women with PCOS. In addition, Myo-inositol also reduces insulin resistance and increases estrogen levels. Myo-inositol reduced testosterone, LH, and insulin levels. The present observation study is to establish efficacy and safety in management of IR and ovarian volume.