Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-30 @ 2:08 PM
Study NCT ID:
NCT01075334
Status:
UNKNOWN
Last Update Posted:
2010-02-25
First Post:
2010-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
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': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2010-02-24', 'studyFirstSubmitQcDate': '2010-02-24', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Rate', 'timeFrame': '3 Insemination cycles', 'description': 'proportion of women becoming pregnancy following treatment with intrauterine insemination'}], 'secondaryOutcomes': [{'measure': 'Sperm quality parameters', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sperm', 'male infertility', 'Carnitine', 'food supplementation', 'insemination'], 'conditions': ['Male Infertility']}, 'referencesModule': {'references': [{'pmid': '16792845', 'type': 'BACKGROUND', 'citation': 'Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. doi: 10.1016/s1472-6483(10)61082-6.'}, {'pmid': '35506389', 'type': 'DERIVED', 'citation': 'de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.'}]}, 'descriptionModule': {'briefSummary': 'Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertility\n* at least one abnormal sperm quality parameter\n* female age \\< 35\n* normal ovarian reserve\n\nExclusion Criteria:\n\n* known allergy to one of the food additives planned for treatment'}, 'identificationModule': {'nctId': 'NCT01075334', 'briefTitle': 'Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'orgStudyIdInfo': {'id': 'porimore.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Porimore arm', 'description': "Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.", 'interventionNames': ['Dietary Supplement: Porimore - A Carnitine based food supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Folate and Zinc', 'interventionNames': ['Dietary Supplement: Zinc and Folate Supplementation']}], 'interventions': [{'name': 'Porimore - A Carnitine based food supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily dose of 2 grams L-carnitine, 1 gr acetyl L-carnitine, 500mg Vitamin C, 400 IU vitamin E, 60 mg Q10, 30mg Zinc Picolinate, 500mcg Folic Acid, 200 Mcg Selenium, 100 MCG Vitamin B12.', 'armGroupLabels': ['Porimore arm']}, {'name': 'Zinc and Folate Supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 Mcg Folic acid, 30-60 mg Zinc tablets/ day', 'armGroupLabels': ['Folate and Zinc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Avi Tsafrir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shaare-Zedek IVF and infertility unit', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Avi Tsafrir, MD', 'role': 'CONTACT', 'email': 'avits@szmc.org.il', 'phone': '972-6555111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Avi Tsafrir, MD', 'oldOrganization': 'IVF Unit, Shaare Zedek Medical Center, Jerusalem, Israel'}}}}