PCOS(Insulin Resistant)NCT07307677
Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
A study testing Metformin 500mg and Melatonin 3mg in people with PCOS(Insulin Resistant), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PCOS(Insulin Resistant)
- What is being tested?
- Metformin 500mg and Melatonin 3mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 Mar 2025to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed case of PCOS according to Rotterdam criteria
- Women of age 18-35 years
- Insulin resistance (HOMA-IR >2.6)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, Shahbag, 1000
Mst Sumyara Medical officer, MS, +8801746046581, sumirmc09@gmail.com
Farzana Rahman, MBBS, +8801914229346, farzana47arshi91@gmail.com
About this study
Official title: Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
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.
Read the 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.
- Conditions
- PCOS(Insulin Resistant)
- Being tested
- Metformin 500mg, Melatonin 3mg
- Keywords
- Melatonin in PCOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 500mgDrug
Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
Melatonin 3mgCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Melatonin and Metformin | Experimental | Participants will receive 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 Receives: Combination Product: Melatonin 3mg |
| Comparator arm: Metformin | Active comparator | Participants will receive Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks Receives: Drug: Metformin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR calculated by the following formula:
HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin mIU/ml divided by 22.5. For the present study HOMA-IR >2.6 can be considered as insulin resistance
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in Body Mass Index (BMI)
Body mass index is calculated by dividing the weight in kg by the height in meter square to assess obesity
Measured: Baseline to 12 weeks
Change in Waist Circumference
Waist Circumference is measured in centimeter by placing a tape horizontally midway between the lower border of ribs and iliac crest on the mid axillary line.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start11 Mar 2025
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PCOS(Insulin Resistant)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label parallel design randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh Medical University
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Jesmine Banu, MS, Study chair, Bangladesh Medical UniversityFarzana Rahman, MBBS, Principal investigator, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307677
- Sponsor's protocol ID
- 5498
- Status last verified
- Mar 2025
- First submitted
- 13 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40047877Ziaei 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.
PubMed 38965577
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
- ClinicalTrials.gov ID
- NCT07307677
- Acronym / sponsor ID
- 5498
- Conditions
- PCOS(Insulin Resistant)
- Keywords
- Melatonin in PCOS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Collaborators
- Bangladesh Medical University
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label parallel design randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Melatonin and Metformin | Experimental | Combination Product: Melatonin 3mgParticipants will receive 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 |
| Comparator arm: Metformin | Active comparator | Drug: Metformin 500mgParticipants will receive Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed case of PCOS according to Rotterdam criteria
- Women of age 18-35 years
- Insulin resistance (HOMA-IR >2.6)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin 500mgMetformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks | Drug | Comparator arm: Metformin |
| Melatonin 3mgMelatonin (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 | Combination product | Experimental arm: Melatonin and Metformin |
Primary outcome
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline to 12 weeks
HOMA-IR calculated by the following formula: HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin mIU/ml divided by 22.5. For the present study HOMA-IR >2.6 can be considered as insulin resistance
2 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline to 12 weeks
Change in Waist Circumference
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 40047877Chen 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.
- Background: PubMed 38965577Ziaei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesmine Banu, MS study chair
Bangladesh Medical University
Farzana Rahman, MBBS principal investigator
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin 500mg and Melatonin 3mg in people with PCOS(Insulin Resistant), run by Mst.Sumyara Khatun at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mst.Sumyara Khatun, MS (+8801746046581, sumirmc09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.