Polycystic Ovary Syndrome (PCOS)NCT07266259
Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women
A study testing Myoinositol and Levo-Carnitine in people with Polycystic Ovary Syndrome (PCOS), run by Mst.Sumyara Khatun at 2 sites in Bangladesh.
Trial summary
The goal of this clinical trial is to learn if combination of levocarnitine and myoinositol works better than myoinositol alone on insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome . It will also learn about the safety of drug levocarnitine and myoinositol. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- Myoinositol and Levo-Carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesBangladesh
- Study dates
- 19 Sep 2025to 1 Mar 2027
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age:18-40 years old.
- Diagnosed cases of PCOS patients(both old \& new cases) according to International evidence-based guideline criteria 2023
- Primary or secondary subfertility.
- Insulin resistance (HOMA-IR >2.6)
Who cannot join
- Hypothyroidism
- Diabetes mellitus
- Hormonal (Myo-inositol,D-chiro-inositol) or insulin sensitizing drugs like Metformin,Pioglitazone etc. treatment in the last three months
- Known hypersensitivity to Myo-inositol and Levo-carnitine
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites, 2 recruiting
- Not yet recruiting
Bangladesh Medical University
Dhaka, Shahbag, 1000
Mst sumiyara khatun
- Recruiting
Bangladesh Medical University
Dhaka, Shahbag, 1000
Mst Sumyara Khatun Medical officer, MS, +8801746046581, sumirmc09@gmail.com
Mst Rebeka sultana, +8801752011780, drrebeka39bcs@gmail.com
About this study
Official title: Effects of Levocarnitine and Myoinositol in Comparison to Myoinositol Alone on Hormonal and Insulin Resistance Parameters in Subfertile Women With Insulin Resistant Polycystic Ovary Syndrome
The goal of this clinical trial is to learn if combination of levocarnitine and myoinositol works better than myoinositol alone on insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome . It will also learn about the safety of drug levocarnitine and myoinositol. The main questions it aims to answer are:
Does combined action of levocarnitine and myoinositol improve insulin resistance and hormonal parameters in comparison to myoinositol alone in subfertile women with insulin resistant polycystic ovary syndrome ? What medical problems do participants have when taking drug levocarnitine and myoinositol? Researchers will compare the drug combination of levocarnitine and myoinositol to myoinositol alone to see if combination therapy works better?
Read more
Participants will:
Take drug levocarnitine and myoinositol or a myoinositol alone twice daily for 3 months Visit the clinic once after 3 months for checkups and tests Keep a diary of their symptoms and the number of times.
Read the detailed description
After obtaining approval of the Institutional Review Board, this randomized controlled trial will be conducted in the department of Reproductive Endocrinology \& Infertility,,Bangladesh Medical University (BMU), Shahbag,Dhaka. A total number of 72 subfertile women with insulin resistance polycystic ovary syndrome, after fulfilling the inclusion and exclusion criteria will be approached for informed written consent after discussing the purpose and procedure of the study. This patient will be collected from REI outdoor department of Reproductive Endocrinology \& Infertility, BMU.Every patient will be asked to come fasting on a particular day, time, and place. Related history will be taken and physical examination (height, weight, waist circumference, hip circumference, acne, hirsutism, acanthosis nigricans) will be done and all data will be documented in a pretested semi-structured questionnaire.
After adequate preparation and precaution, about 04 ml of venous blood will be drawn from each participant after 8-12 hours of fasting.
About4 ml of whole blood collected during fasting, 2 ml will be kept in a fluorinated tube for measuring fasting blood glucose (FBG), and 2 ml of blood for serum collection, will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, the fluorinated tube and adequate serum will be tested for fasting blood sugar andserum fasting insulin on the same collection day in department of biochemistry and molecular biology,BMU.Fasting blood glucose by glucose oxidase method,fasting insulin by chemiluminescent technology by atellicaIM IRI assay in BMU. Then HOMA-IR will be calculated.If HOMA-IR index >2.6 ,then patient will be asked to come on their second day of menstruation.After adequate preparation and precaution, about 4 ml of venous blood will be drawn from each participant,will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, adequate serum will be tested for serum follicle stimulating hormone(FSH),serum luteinizing hormone(LH) by chemiluminescence immunoassay(ADVIA Centaur XPT Immunoassay) and serum free testosterone level by chemiluminescence (MAGLUMI X8) on the same collection day in microbiology \& immunology department of BMU.
Detailed socio-demographic data, history,examination findings and investigations will be recorded in a predesigned data sheet.
Eligible women who will give their informed consent will be randomized into two groups. Allocation concealment will be done by serially numbered sealed envelopes. Each envelope will be labeled with a serial number and will have a card noting the intervention type. Allocation will never be changed after opening the sealed envelopes.
The experimental group will be treated with levocarnitine 330mg and myoinositol 750mg twice daily for 3 months.The comparator group will be treated with myoinositol 750 mg twice daily alone for 3 months.Then monthly over phone follow-up will be given about the patient's compliance. Any adverse events or side effects related to supplementation will be recorded and managed accordingly.
They will also be informed not to take other medications except after consulting with us.
After 3 months of intervention patients will come at Reproductive Endocrinology Infertility department on their second day(D2) of menstruation with 8-12 hours fasting. Then I will check strip of drug whether patient had taken the drug properly or not. Fasting blood sugar,fasting insulin,serum FSH,LH,free testosterone will be done by the same procedure.
Then data will be collected from the patients on using interviews, observation, clinical examination, investigations. The cumulative data will be subjected to analysis. All the clinical, biochemical and hormonal information will be documented in a pretested,semi structured clinical case record form.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- Myoinositol, Levo-Carnitine
- Keywords
- levocarnitine myoinositol, insulin resistance hormonal parameters, polycystic ovary syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoinositolDietary supplement
Myoinositol 750mg twice daily for 3 months
Levo-CarnitineCombination product
Also called Myoinositol
Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm:( Levocarnitine and myoinositol) | Experimental | Participants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months Receives: Combination Product: Levo-Carnitine |
| Active Comparator (Myoinositol) | Active comparator | Participants will receive myoinositol 750mg twice daily for 3 months Receives: Dietary Supplement: Myoinositol |
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 will be calculated as (fasting insulin(micro IU/mL*fasting glucose(mmol/L)/22.5
Measured: Baseline to 12 weeks after treatment
Secondary outcomes (4)
Change in serum LH level
Serum LH level will be measured on day 2 of the menstrual cycle by Chemiluminescence immunoassay [ADVIA Centaur XPT ImmunoassaySystem].D2-D5 Serum LH-5-20IU/L.
Measured: Baseline and after 12 weeks of treatment
Change in serum FSH level
Serum FSH level will be measured on day 2of the menstrual cycle by Chemiluminescence immunoassay [ADVIA Centaur XPTImmunoassay System].(D2-D5) Serum FSH-5-20IU/L
Measured: baseline and 12 weeks after treatment
Change in LH:FSH ratio
The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by FSH mIU/mL).
Measured: baseline and 12 weeks after treatment
Change in serum free testosterone
Free testosterone will bemeasured on menstrual day 2 by Chemiluminescence immunoassay [MAGLUMI X8, Germany]. Normal value for a female is 0.7 to 3.6 pg/mL
Measured: baseline and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start19 Sep 2025
- Primary completion18 Aug 2026 (estimated)
- Study completion1 Mar 2027 (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 Polycystic Ovary Syndrome (PCOS)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 randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mst.Sumyara Khatun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mst.Sumyara Khatun, Bangladesh Medical University
- Investigators
- Jemine Banu, MS, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266259
- Sponsor's protocol ID
- 5722
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Genazzani AD, Battipaglia C, Foschi M, Semprini E, Aio C, Spelta E, Kostrzak A, Rusce ML, Szeliga A, Meczekalski B. Improved insulin sensitivity and reproductive profile in overweight/obese PCOS patients undergoing integrative treatment with carnitines, L-arginine, L-cysteine and myo-inositol. Gynecol Endocrinol. 2025 Dec;41(1):2458710. doi: 10.1080/09513590.2025.2458710. Epub 2025 Jan 28.
PubMed 39874141Agarwal A, Sengupta P, Durairajanayagam D. Role of L-carnitine in female infertility. Reprod Biol Endocrinol. 2018 Jan 26;16(1):5. doi: 10.1186/s12958-018-0323-4.
PubMed 29373970
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Levocarnitine and Myoinositol in Comparison to Myoinositol Alone on Hormonal and Insulin Resistance Parameters in Subfertile Women With Insulin Resistant Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07266259
- Acronym / sponsor ID
- 5722
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- levocarnitine myoinositol, insulin resistance hormonal parameters, polycystic ovary syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mst.Sumyara KhatunUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 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.
The goal of this clinical trial is to learn if combination of levocarnitine and myoinositol works better than myoinositol alone on insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome . It will also learn about the safety of drug levocarnitine and myoinositol. The main questions it aims to answer are:
Does combined action of levocarnitine and myoinositol improve insulin resistance and hormonal parameters in comparison to myoinositol alone in subfertile women with insulin resistant polycystic ovary syndrome ? What medical problems do participants have when taking drug levocarnitine and myoinositol? Researchers will compare the drug combination of levocarnitine and myoinositol to myoinositol alone to see if combination therapy works better?
Participants will:
Take drug levocarnitine and myoinositol or a myoinositol alone twice daily for 3 months Visit the clinic once after 3 months for checkups and tests Keep a diary of their symptoms and the number of times.
Detailed description
After obtaining approval of the Institutional Review Board, this randomized controlled trial will be conducted in the department of Reproductive Endocrinology \& Infertility,,Bangladesh Medical University (BMU), Shahbag,Dhaka. A total number of 72 subfertile women with insulin resistance polycystic ovary syndrome, after fulfilling the inclusion and exclusion criteria will be approached for informed written consent after discussing the purpose and procedure of the study. This patient will be collected from REI outdoor department of Reproductive Endocrinology \& Infertility, BMU.Every patient will be asked to come fasting on a particular day, time, and place. Related history will be taken and physical examination (height, weight, waist circumference, hip circumference, acne, hirsutism, acanthosis nigricans) will be done and all data will be documented in a pretested semi-structured questionnaire.
After adequate preparation and precaution, about 04 ml of venous blood will be drawn from each participant after 8-12 hours of fasting.
About4 ml of whole blood collected during fasting, 2 ml will be kept in a fluorinated tube for measuring fasting blood glucose (FBG), and 2 ml of blood for serum collection, will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, the fluorinated tube and adequate serum will be tested for fasting blood sugar andserum fasting insulin on the same collection day in department of biochemistry and molecular biology,BMU.Fasting blood glucose by glucose oxidase method,fasting insulin by chemiluminescent technology by atellicaIM IRI assay in BMU. Then HOMA-IR will be calculated.If HOMA-IR index >2.6 ,then patient will be asked to come on their second day of menstruation.After adequate preparation and precaution, about 4 ml of venous blood will be drawn from each participant,will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, adequate serum will be tested for serum follicle stimulating hormone(FSH),serum luteinizing hormone(LH) by chemiluminescence immunoassay(ADVIA Centaur XPT Immunoassay) and serum free testosterone level by chemiluminescence (MAGLUMI X8) on the same collection day in microbiology \& immunology department of BMU.
Detailed socio-demographic data, history,examination findings and investigations will be recorded in a predesigned data sheet.
Eligible women who will give their informed consent will be randomized into two groups. Allocation concealment will be done by serially numbered sealed envelopes. Each envelope will be labeled with a serial number and will have a card noting the intervention type. Allocation will never be changed after opening the sealed envelopes.
The experimental group will be treated with levocarnitine 330mg and myoinositol 750mg twice daily for 3 months.The comparator group will be treated with myoinositol 750 mg twice daily alone for 3 months.Then monthly over phone follow-up will be given about the patient's compliance. Any adverse events or side effects related to supplementation will be recorded and managed accordingly.
They will also be informed not to take other medications except after consulting with us.
After 3 months of intervention patients will come at Reproductive Endocrinology Infertility department on their second day(D2) of menstruation with 8-12 hours fasting. Then I will check strip of drug whether patient had taken the drug properly or not. Fasting blood sugar,fasting insulin,serum FSH,LH,free testosterone will be done by the same procedure.
Then data will be collected from the patients on using interviews, observation, clinical examination, investigations. The cumulative data will be subjected to analysis. All the clinical, biochemical and hormonal information will be documented in a pretested,semi structured clinical case record form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental arm:( Levocarnitine and myoinositol) | Experimental | Combination Product: Levo-CarnitineParticipants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months |
| Active Comparator (Myoinositol) | Active comparator | Dietary Supplement: MyoinositolParticipants will receive myoinositol 750mg twice daily for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age:18-40 years old.
- Diagnosed cases of PCOS patients(both old \& new cases) according to International evidence-based guideline criteria 2023
- Primary or secondary subfertility.
- Insulin resistance (HOMA-IR >2.6)
Key exclusion criteria (5 listed)
- Hypothyroidism
- Diabetes mellitus
- Hormonal (Myo-inositol,D-chiro-inositol) or insulin sensitizing drugs like Metformin,Pioglitazone etc. treatment in the last three months
- Known hypersensitivity to Myo-inositol and Levo-carnitine
- Pregnancy
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 |
|---|---|---|
| MyoinositolMyoinositol 750mg twice daily for 3 months | Dietary supplement | Active Comparator (Myoinositol) |
| Levo-CarnitineAlso: MyoinositolLevocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months | Combination product | Experimental arm:( Levocarnitine and myoinositol) |
Primary outcome
Change in homeostatic model assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline to 12 weeks after treatment
HOMA-IR will be calculated as (fasting insulin(micro IU/mL*fasting glucose(mmol/L)/22.5
4 secondary outcomes
Change in serum LH level
Time frame: Baseline and after 12 weeks of treatment
Change in serum FSH level
Time frame: baseline and 12 weeks after treatment
Change in LH:FSH ratio
Time frame: baseline and 12 weeks after treatment
Change in serum free testosterone
Time frame: baseline and 12 weeks after treatment
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 19 Dec 2025.
- Background: PubMed 39874141Genazzani AD, Battipaglia C, Foschi M, Semprini E, Aio C, Spelta E, Kostrzak A, Rusce ML, Szeliga A, Meczekalski B. Improved insulin sensitivity and reproductive profile in overweight/obese PCOS patients undergoing integrative treatment with carnitines, L-arginine, L-cysteine and myo-inositol. Gynecol Endocrinol. 2025 Dec;41(1):2458710. doi: 10.1080/09513590.2025.2458710. Epub 2025 Jan 28.
- Background: PubMed 29373970Agarwal A, Sengupta P, Durairajanayagam D. Role of L-carnitine in female infertility. Reprod Biol Endocrinol. 2018 Jan 26;16(1):5. doi: 10.1186/s12958-018-0323-4.
- Individual participant dataSharing planned: Undecided
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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.
Jemine Banu, MS study director
Bangladesh Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myoinositol and Levo-Carnitine in people with Polycystic Ovary Syndrome (PCOS), run by Mst.Sumyara Khatun at 2 sites 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 4 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 after treatment). 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 NCT07266259, 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 19 Dec 2025.