Bariatric Surgery and Sperm Quality

Study Overview
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Brief Summary
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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.

Detailed Description
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In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits : 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

Official Title
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Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study

Conditions
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Obesity, Bariatric Surgery

Intervention / Treatment
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* Other: Blood and sperm samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities 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: Not candidates for surgery With non idiopathic alteration of spermatogenesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Bariatric surgery<br>Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team | Other: Blood and sperm samples<br>* Blood and sperm samples will be done in each visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total spermatozoids (NTS) variation | Comparison before/after surgery | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of total spermatozoids (NTS) variation | Comparison before/after surgery | 1 year after surgery | 
| sperm caracteristics | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Effect of biological parameters on NTS variation | Comparison before/after surgery and search of correlation | 6 months and 1 year after surgery | 
| Evaluation of environmental parameters : physical activity | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Other spermatic parameters : DNA fragmentation | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Other spermatic parameters : CASA | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Effect of anthropometric parameters on NTS variation | Comparison before/after surgery and search of correlation | 6 months and 1 year after surgery | 
| Evaluation of environmental parameters : tobacco consumption | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Evaluation of environmental parameters : libido | Comparison before/after surgery | 6 months and 1 year after surgery | 
| Evaluation of environmental parameters : quality of life | Comparison before/after surgery | 6 months and 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric surgery, Sperm quality, Fertility