Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2013-02-15
2016-03-25
Brief Summary
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Detailed Description
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First visit (inclusion, before surgery) :
* Signature of consent
* 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))
* Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
* Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
* Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)
Bariatric surgery
Second visit (6 month follow-up)
* Report of adverse events if any
* Surveys
* Blood and sperm samples
Third visit (12 month follow-up)
* Report of adverse events if any
* Blood and sperm samples
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Bariatric surgery
Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
Blood and sperm samples
Blood and sperm samples will be done in each visit
Interventions
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Blood and sperm samples
Blood and sperm samples will be done in each visit
Eligibility Criteria
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Inclusion Criteria
* Selected for bariatric surgery by multidisciplinary team
* From 18 to 50 years old included
* With a first medical consultation and its results
* With their written informed consent to participate in the study
* No problem for understanding verbal or written French
* An affiliation to social security
Exclusion Criteria
* With non idiopathic alteration of spermatogenesis
18 Years
50 Years
MALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Rachel Levy, MD
Role: STUDY_CHAIR
Jean Verdier Hospital
Locations
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Jean Verdier Hospital
Bondy, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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AOM11193
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P110153
Identifier Type: -
Identifier Source: org_study_id
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