Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women
NCT ID: NCT07266259
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2025-09-19
2027-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental arm:( Levocarnitine and myoinositol)
Participants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months
Levo-Carnitine
Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months
Active Comparator (Myoinositol)
Participants will receive myoinositol 750mg twice daily for 3 months
Myoinositol
Myoinositol 750mg twice daily for 3 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Myoinositol
Myoinositol 750mg twice daily for 3 months
Levo-Carnitine
Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mst.Sumyara Khatun
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mst.Sumyara Khatun
Medical Officer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jemine Banu, MS
Role: STUDY_DIRECTOR
Bangladesh Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bangladesh Medical University
Dhaka, Shahbag, Bangladesh
Bangladesh Medical University
Dhaka, Shahbag, Bangladesh
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mst sumiyara khatun
Role: primary
Mst Sumyara Khatun Medical officer, MS
Role: primary
Mst Rebeka sultana
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
Agarwal 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5722
Identifier Type: -
Identifier Source: org_study_id