Bariatric Surgery, Obesity
Conditions
Keywords
Obesity, Bariatric surgery, Sperm quality, Fertility
Brief summary
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
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
Interventions
Blood and sperm samples will be done in each visit
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of total spermatozoids (NTS) variation | 6 months after surgery | Comparison before/after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of total spermatozoids (NTS) variation | 1 year after surgery | Comparison before/after surgery |
| sperm caracteristics | 6 months and 1 year after surgery | Comparison before/after surgery |
| Effect of biological parameters on NTS variation | 6 months and 1 year after surgery | Comparison before/after surgery and search of correlation |
| Evaluation of environmental parameters : physical activity | 6 months and 1 year after surgery | Comparison before/after surgery |
| Evaluation of environmental parameters : quality of life | 6 months and 1 year after surgery | Comparison before/after surgery |
| Other spermatic parameters : CASA | 6 months and 1 year after surgery | Comparison before/after surgery |
| Effect of anthropometric parameters on NTS variation | 6 months and 1 year after surgery | Comparison before/after surgery and search of correlation |
| Evaluation of environmental parameters : tobacco consumption | 6 months and 1 year after surgery | Comparison before/after surgery |
| Evaluation of environmental parameters : libido | 6 months and 1 year after surgery | Comparison before/after surgery |
| Other spermatic parameters : DNA fragmentation | 6 months and 1 year after surgery | Comparison before/after surgery |
Countries
France
Outcome results
None listed