Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial

After obtaining approval of the Institutional Review Board (IRB), this randomized clinical trial was conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. Already diagnosed patients of polycystic ovary syndrome with infertilitywithHOMA-IR>2.0attendingintheOPDofReproductiveEndocrinology and Infertility Department at BSMMU were the study population. After approval of protocol, women with PCOS fulfilling inclusion and exclusion criteria were explained in detail regarding the objectives, rationality, procedure, and potential benefits of the study. The patients were counseled regarding the drugs and unexpected side-effects and an informed written consent was taken.

Those who gave voluntary informed consent were randomized to any of the two treatment arms.Afterenrollmentofthepatients, allocation was doneby computerized permuted block randomization. Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labeled with a serial number and had a card inside notingthe intervention drug. Allocation never changed after opening the closed envelope. Eligible women were randomly allocated into two groups:

Experimental group: Myoinositol group:Tab Myoinositol (Tab Myosit, Renata Pharmaceutical Limited)750mg was given three times daily for 3 months

Controlgroup:D-chiro-inositol group: Cap D-chiro-inositol (Cap Chirocyst,Radiant Pharmaceutical Limited) 500 mg was given once daily for 3 months.

Data were collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessment including demographic and clinical information (age, weight, height, BMI, waist circumference, hirsutism, acne, acanthosis nigricans)and the result of baseline investigations were undertaken. All the data were enrolled in the clinical record form for this study.