Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin 500mg, Melatonin 3mg.
- Who it may be relevant to
- Registry conditions: PCOS(Insulin Resistant). Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
Overview
Women with polycystic ovary syndrome with HOMA-IR \>2.6 fulfilling inclusion and exclusion criteria will be randomly allocated into two groups:experimental group: A (Melatonin 3mg and Metformin 500mg) and control group: B (Metformin 500mg). Each group will be contained 30 selected patients. Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.
Detailed description
After obtaining approval of the Institutional Review Board (IRB), this randomized controlled trial will be conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU). Already diagnosed patients of polycystic ovary syndrome with subfertility with HOMA-IR \>2.6 attending in the OPD of Reproductive Endocrinology and Infertility department at BSMMU will be the study population. Women with PCOS fulfilling inclusion and exclusion criteria will be explained in details regarding the objectives, rationality, procedure and potential benefits of the study. The patients will be counselled regarding the drugs and side effects and Informed written consent will be obtained before enrollment.Random allocation will be done using serially numbered closed opaque envelopes. Eligible women will be randomly allocated into two groups:experimental group: A and control group: B. Each group will be contained 30 selected patients.
Group A:Tab. Melatonin (3mg) 3 tablet once daily at night for 12 weeks with Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.
Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.
Data will be collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessments including demographic and clinical information and the result of baseline investigations will be undertaken.
Follow up: Participants will come after one month to assess compliance with the regimen and monitor for any potential side effects. A third visit will be scheduled at the end of the third month for a comprehensive assessment. Any adverse events experienced by participants will be carefully noted and documented throughout the study duration. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.
Interventions
- Drug Metformin 500mg
Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks - Combination product Melatonin 3mg
Melatonin (3mg) 3 tablet single dose at night for 12 weeks and Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
Primary outcome measures
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: Baseline to 12 weeks]
Secondary outcome measures (2)
- Change in Body Mass Index (BMI) [Time frame: Baseline to 12 weeks]
- Change in Waist Circumference [Time frame: Baseline to 12 weeks]
Eligibility criteria
Inclusion criteria
- Diagnosed case of PCOS according to Rotterdam criteria
- Women of age 18-35 years
- Insulin resistance (HOMA-IR >2.6)
Exclusion criteria
- BMI: ≤ 18.5 and ≥ 30 kg/m2
- Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia)
- Known case of any medical disease (Renal, hepatic or cardiac disease)
- Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months.
- Hypersensitivity to melatonin.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Bangladesh Medical University — Dhaka
Publications
- Chen W, Zhang H, Guo B, Tao Y, Zhang J, Wang J, Chen G, Cheng M, Hong Q, Cao Y, Xie F. Melatonin refines ovarian mitochondrial dysfunction in PCOS by regulating the circadian rhythm gene Clock. Cell Mol Life Sci. 2025 Mar 6;82(1):104. doi: 10.1007/s00018-025-05609-9. PMID 40047877
- Ziaei S, Hasani M, Malekahmadi M, Daneshzad E, Kadkhodazadeh K, Heshmati J. Effect of melatonin supplementation on cardiometabolic risk factors, oxidative stress and hormonal profile in PCOS patients: a systematic review and meta-analysis of randomized clinical trials. J Ovarian Res. 2024 Jul 4;17(1):138. doi: 10.1186/s13048-024-01450-z. PMID 38965577
Identifiers
NCT: NCT07307677 · 5498