Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 1:38 PM
Study NCT ID:
NCT05847257
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2023-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective clinical study. The study initially included 74 patients, on follow-up 7 cases were lost and the final analysis involved 67 cases. These patients were further divided into two groups randomly, group A (29) patients received letrozole 2.5mg twice weekly for 3 months, and group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months.\n\nPatients with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome were selected during their visit to the specialized center of infertility/ Nahrain University. Before taking part, each subject provided their written, informed consent. The duration of this study was from December 2021 till October 2022.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-15', 'studyFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The seminal fluid analysis', 'timeFrame': 'change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment', 'description': 'sperm volume/ ml, Sperm concentration/ml, Total sperm count / ml, Progressive Sperm motility (%), Non-progressive Sperm motility (%), Immotile Sperm (%), Normal Sperm morphology (%)'}], 'secondaryOutcomes': [{'measure': 'hormone profile', 'timeFrame': 'change in value from baseline to the end of 1st, 2nd and 3rd month for three consecutive months of treatment', 'description': 'concentration of Serum FSH, concentration of Serum estradiol, and concentration of Serum testosterone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Reproductive Problem', 'Infertility, Male']}, 'referencesModule': {'availIpds': [{'id': '10.5281/zenodo.', 'url': 'https://zenodo.org/records/8191740', 'type': 'Individual Participant Data Set', 'comment': 'data of impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study'}], 'references': [{'pmid': '38957201', 'type': 'DERIVED', 'citation': 'Fadhil EB, Mohammed MM, Alkawaz UM. Impact of coenzyme Q10 as an adjuvant therapy to letrozole on spermiogram results and sex hormone levels in Iraqi men with infertility; randomized open label comparative study. F1000Res. 2024 Jun 10;12:1093. doi: 10.12688/f1000research.131985.3. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://f1000research.com/articles/12-1093/v3', 'label': 'Publication'}]}, 'descriptionModule': {'briefSummary': "Worldwide infertility affects about 15 % of reproductive-age couples. In many cases, infertility can't be treated, new treatment options with promising value were involved in the recent clinical trials.", 'detailedDescription': 'We will evaluate the impacts of adding coenzyme Q10 to letrozole on spermiogram and sex hormone in men diagnosed with idiopathic oligo/astheno/ teratozoospermia (iOAT) syndrome.\n\nThe study will include 67 patients which will be randomly separated into two groups, Group (A) 29 patients will be treated with letrozole 2.5mg tablet orally twice a week, Group (B) 38 patient will be treated with a combination of letrozole 2.5 mg tablet orally twice a week plus Co-Q10 400mg per day, both groups complete treatment for three months. Semen sample, serum FSH, estradiol (E2), and testosterone (T) were analyzed at day one, and at the end of one, two, and three months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult male patients.\n2. Aged 18 - 60 years.\n3. Confirmed diagnosis with idiopathic Oligo-Astheno-Teratozoospermia (iOAT) syndrome.\n\nExclusion Criteria:\n\n1. Patients who have been found to have additional infertility causes, such as varicocele or Obstruction of the ejaculatory duct.\n2. Those who have had surgery for male factor infertility.\n3. Patients with infections such as STD.\n4. Patient with renal or liver disease\n5. Incomplete patient data'}, 'identificationModule': {'nctId': 'NCT05847257', 'briefTitle': 'Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram', 'organization': {'class': 'OTHER', 'fullName': 'Al-Mustansiriyah University'}, 'officialTitle': 'Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram and Sex Hormone in Iraqi Infertile Men; A Comparative Study', 'orgStudyIdInfo': {'id': '2023M01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Group A', 'description': 'group A (29) patients received letrozole 2.5mg twice weekly for 3 months', 'interventionNames': ['Drug: Letrozole tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B (38) patients receive letrozole 2.5mg twice a week plus Co Q10 400 mg per day for 3 months', 'interventionNames': ['Drug: Letrozole tablets', 'Dietary Supplement: Coenzyme Q10 table']}], 'interventions': [{'name': 'Letrozole tablets', 'type': 'DRUG', 'description': 'letrozole 2.5mg twice weekly for 3 months', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'Coenzyme Q10 table', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Coenzyme Q10 400 mg per day for 3 months', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12221', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'specialized center of infertility/ Nahrain University', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Upon publication of the study', 'ipdSharing': 'YES', 'description': 'All participants demographical and clinical characteristics, and outcome of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Mustansiriyah University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Nahrain University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associated professor', 'investigatorFullName': 'Mohammed Mahmood Mohammed', 'investigatorAffiliation': 'Al-Mustansiriyah University'}}}}