Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-25 @ 1:50 AM
Study NCT ID:
NCT04177667
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind placebo controlled trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-22', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of sperm concentration (millions/ml) on spermogram of infertile men', 'timeFrame': '6 months', 'description': 'Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.'}, {'measure': 'Evaluation of sperm motility (%) on spermogram of infertile men', 'timeFrame': '6 months', 'description': 'Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.'}, {'measure': 'Evaluation of sperm normal morphology (%) on spermogram of infertile men', 'timeFrame': '6 months', 'description': 'Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pregnancy rate (number)', 'timeFrame': '6 months', 'description': 'Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Infertility']}, 'descriptionModule': {'briefSummary': 'Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.\n\nThis randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men with oligo- and/or astheno- and/or terato-zoospermia\n* with or without varicocele\n* men aged between 18 and 50 years\n* men from couples with history of difficulty conceiving for more than 12 months\n\nExclusion Criteria:\n\n* subjects with known hypersensitivity to any of the treatment compound\n* history of undescended testes or cancer\n* endocrine disorders\n* history of post-pubertal mumps\n* genitourinary surgery\n* obstructive azoospermia or obstructive pathology of the urogenital system\n* autoimmune disease\n* cystic fibrosis\n* history of taking any therapy affecting fertility within last 3 months\n* excessive consumption of alcohol or regular use of illicit or "recreational" drugs\n* positive serology for HIV\n* subjects following any special diet\n* any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials'}, 'identificationModule': {'nctId': 'NCT04177667', 'briefTitle': 'Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'PXP-001A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Proxeed arm', 'description': 'Subjects received 2 packets per day for 6 months of supplement (1000 mg of L-carnitine, 725 mg of fumarate, 500 mg of acetyl-L-carnitine, 1000 mg of fructose, 50 mg of citric acid, 50 µg of selenium, 20 mg of coenzyme Q10, 90 mg of vitamin C, 10 mg of zinc, 200 µg of folic acid and 1.5 µg of vitamin B12)', 'interventionNames': ['Dietary Supplement: Proxeed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Subjects received 2 packets per day for 6 months of placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Proxeed', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment with dietary supplement for male infertility for Proxeed Arm', 'armGroupLabels': ['Proxeed arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Treatment with placebo for Placebo Arm', 'armGroupLabels': ['Placebo arm']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ettore De Berardinis', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}