Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial
Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial
This randomized controlled trial was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU.A total of 80 infertile women ofPCOS withinsulinresistanceparticipatedinthestudyandwere randomly allocated into 2 groups. One group was treated with tab. Myoinositol (MI) 750 mg thrice daily and other group with D-chiro-inositol (DCI) 500 mg once daily for 3 months. After 3 months, follow up fasting blood sugar, fasting insulin and HOMA-IR were measured
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.
Follow up:
During the study period, patients were contacted every monthover telephone and inquired about the compliance to the regimen as well as any side effects.Second visit was scheduled at the end of 3rd month to assess the treatment outcome.
End points:
After the allotted study period of 3 months, fasting blood samples were collected to estimate fasting blood sugar level and fasting insulin. HOMA-IR was calculated using specific formula and comparison was made between the effect of myo-inositol and D-chiro-inositolon insulin resistance parameters in infertile women with polycystic ovary syndrome.
For each and every subject, a separate clinical record form was prepared. Data were collected from the patients on different visits on variables of interest using interview, observation, clinical examination, investigations and from the history sheet of the patients. The cumulative data were then subjected to analysis.
Inclusion Criteria:
Exclusion Criteria: