Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT07266259
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in homeostatic model assessment of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline to 12 weeks after treatment', 'description': 'HOMA-IR will be calculated as (fasting insulin(micro IU/mL\\*fasting glucose(mmol/L)/22.5'}], 'secondaryOutcomes': [{'measure': 'Change in serum LH level', 'timeFrame': 'Baseline and after 12 weeks of treatment', 'description': '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.'}, {'measure': 'Change in serum FSH level', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': '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'}, {'measure': 'Change in LH:FSH ratio', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': 'The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by FSH mIU/mL).'}, {'measure': 'Change in serum free testosterone', 'timeFrame': 'baseline and 12 weeks after treatment', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levocarnitine myoinositol', 'insulin resistance hormonal parameters', 'polycystic ovary syndrome'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)']}, 'referencesModule': {'references': [{'pmid': '39874141', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29373970', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nParticipants will:\n\nTake 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.', 'detailedDescription': "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.\n\nAfter adequate preparation and precaution, about 04 ml of venous blood will be drawn from each participant after 8-12 hours of fasting.\n\nAbout4 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.\n\nDetailed socio-demographic data, history,examination findings and investigations will be recorded in a predesigned data sheet.\n\nEligible 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.\n\nThe 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.\n\nThey will also be informed not to take other medications except after consulting with us.\n\nAfter 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.\n\nThen 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age:18-40 years old.\n* Diagnosed cases of PCOS patients(both old \\& new cases) according to International evidence-based guideline criteria 2023\n* Primary or secondary subfertility.\n* Insulin resistance (HOMA-IR \\>2.6)\n\nExclusion Criteria:\n\n* Hypothyroidism\n* Diabetes mellitus\n* Hormonal (Myo-inositol,D-chiro-inositol) or insulin sensitizing drugs like Metformin,Pioglitazone etc. treatment in the last three months\n* Known hypersensitivity to Myo-inositol and Levo-carnitine\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07266259', 'briefTitle': 'Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '5722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm:( Levocarnitine and myoinositol)', 'description': 'Participants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months', 'interventionNames': ['Combination Product: Levo-Carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator (Myoinositol)', 'description': 'Participants will receive myoinositol 750mg twice daily for 3 months', 'interventionNames': ['Dietary Supplement: Myoinositol']}], 'interventions': [{'name': 'Myoinositol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Myoinositol 750mg twice daily for 3 months', 'armGroupLabels': ['Active Comparator (Myoinositol)']}, {'name': 'Levo-Carnitine', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Myoinositol'], 'description': 'Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months', 'armGroupLabels': ['Experimental arm:( Levocarnitine and myoinositol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'state': 'Shahbag', 'status': 'NOT_YET_RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Mst sumiyara khatun', 'role': 'CONTACT'}], 'facility': 'Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'zip': '1000', 'city': 'Dhaka', 'state': 'Shahbag', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Mst Sumyara Khatun Medical officer, MS', 'role': 'CONTACT', 'email': 'sumirmc09@gmail.com', 'phone': '+8801746046581'}, {'name': 'Mst Rebeka sultana', 'role': 'CONTACT', 'email': 'drrebeka39bcs@gmail.com', 'phone': '+8801752011780'}, {'name': 'Mst rebeka sultana', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jemine Banu, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Mst.Sumyara Khatun, MS', 'role': 'CONTACT', 'email': 'sumirmc09@gmail.com', 'phone': '+8801746046581'}, {'name': 'Mst Rebeka sultana, MBBS', 'role': 'CONTACT', 'email': 'drrebeka39bcs@gmail.com', 'phone': '+8801752011780'}], 'overallOfficials': [{'name': 'Jemine Banu, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bangladesh Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mst.Sumyara Khatun', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Officer', 'investigatorFullName': 'Mst.Sumyara Khatun', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}