Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT01842295
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2013-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Surgery and Sperm Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of total spermatozoids (NTS) variation', 'timeFrame': '6 months after surgery', 'description': 'Comparison before/after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of total spermatozoids (NTS) variation', 'timeFrame': '1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'sperm caracteristics', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Effect of biological parameters on NTS variation', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery and search of correlation'}, {'measure': 'Evaluation of environmental parameters : physical activity', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Other spermatic parameters : DNA fragmentation', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Other spermatic parameters : CASA', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Effect of anthropometric parameters on NTS variation', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery and search of correlation'}, {'measure': 'Evaluation of environmental parameters : tobacco consumption', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Evaluation of environmental parameters : libido', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}, {'measure': 'Evaluation of environmental parameters : quality of life', 'timeFrame': '6 months and 1 year after surgery', 'description': 'Comparison before/after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Bariatric surgery', 'Sperm quality', 'Fertility'], 'conditions': ['Obesity', 'Bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '31147284', 'type': 'BACKGROUND', 'citation': 'Carette C, Levy R, Eustache F, Baron G, Coupaye M, Msika S, Barrat C, Cohen R, Catheline JM, Brugnon F, Slim K, Barsamian C, Chevallier JM, Bretault M, Bouillot JL, Antignac JP, Rives-Lange C, Ravaud P, Czernichow S. Changes in total sperm count after gastric bypass and sleeve gastrectomy: the BARIASPERM prospective study. Surg Obes Relat Dis. 2019 Aug;15(8):1271-1279. doi: 10.1016/j.soard.2019.04.019. Epub 2019 Apr 25.'}, {'pmid': '32891457', 'type': 'BACKGROUND', 'citation': 'Mifsud F, Czernichow S, Carette C, Levy R, Ravaud P, Cynober L, Neveux N, Rives-Lange C; Bariasperm Study Group. Behaviour of plasma citrulline after bariatric surgery in the BARIASPERM cohort. Clin Nutr. 2021 Feb;40(2):505-510. doi: 10.1016/j.clnu.2020.05.045. Epub 2020 Jun 12.'}, {'pmid': '15618249', 'type': 'BACKGROUND', 'citation': 'di Frega AS, Dale B, Di Matteo L, Wilding M. Secondary male factor infertility after Roux-en-Y gastric bypass for morbid obesity: case report. Hum Reprod. 2005 Apr;20(4):997-8. doi: 10.1093/humrep/deh707. Epub 2004 Dec 23.'}, {'pmid': '19889752', 'type': 'BACKGROUND', 'citation': 'MacDonald AA, Herbison GP, Showell M, Farquhar CM. The impact of body mass index on semen parameters and reproductive hormones in human males: a systematic review with meta-analysis. Hum Reprod Update. 2010 May-Jun;16(3):293-311. doi: 10.1093/humupd/dmp047. Epub 2009 Nov 4.'}, {'pmid': '22196889', 'type': 'BACKGROUND', 'citation': 'Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Levy R. Sperm parameters and male fertility after bariatric surgery: three case series. Reprod Biomed Online. 2012 Feb;24(2):206-10. doi: 10.1016/j.rbmo.2011.10.014. Epub 2011 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.', 'detailedDescription': 'In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :\n\nFirst visit (inclusion, before surgery) :\n\n* Signature of consent\n* Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))\n* Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)\n* Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)\n* Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)\n\nBariatric surgery\n\nSecond visit (6 month follow-up)\n\n* Report of adverse events if any\n* Surveys\n* Blood and sperm samples\n\nThird visit (12 month follow-up)\n\n* Report of adverse events if any\n* Blood and sperm samples'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities\n* Selected for bariatric surgery by multidisciplinary team\n* From 18 to 50 years old included\n* With a first medical consultation and its results\n* With their written informed consent to participate in the study\n* No problem for understanding verbal or written French\n* An affiliation to social security\n\nExclusion Criteria:\n\n* Not candidates for surgery\n* With non idiopathic alteration of spermatogenesis'}, 'identificationModule': {'nctId': 'NCT01842295', 'acronym': 'BARIASPERM', 'briefTitle': 'Bariatric Surgery and Sperm Quality', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study', 'orgStudyIdInfo': {'id': 'P110153'}, 'secondaryIdInfos': [{'id': 'AOM11193', 'type': 'OTHER_GRANT', 'domain': 'Programme Hospitalier de Recherche Clinique (PHRC)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Bariatric surgery', 'description': 'Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team', 'interventionNames': ['Other: Blood and sperm samples']}], 'interventions': [{'name': 'Blood and sperm samples', 'type': 'OTHER', 'description': 'Blood and sperm samples will be done in each visit', 'armGroupLabels': ['Bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93140', 'city': 'Bondy', 'country': 'France', 'facility': 'Jean Verdier Hospital', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}], 'overallOfficials': [{'name': 'Rachel Levy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jean Verdier Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}