Bariatric Surgery and Sperm Quality
- Conditions
- ObesityBariatric Surgery
- Interventions
- Other: Blood and sperm samples
- Registration Number
- NCT01842295
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 46
- 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
- Not candidates for surgery
- With non idiopathic alteration of spermatogenesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bariatric surgery Blood and sperm samples Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
- Primary Outcome Measures
Name Time Method Number of total spermatozoids (NTS) variation 6 months after surgery Comparison before/after surgery
- Secondary Outcome Measures
Name Time Method Evaluation of environmental parameters : quality of life 6 months and 1 year after surgery Comparison before/after surgery
Number of total spermatozoids (NTS) variation 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
Other spermatic parameters : DNA fragmentation 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
Evaluation of environmental parameters : physical activity 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
sperm caracteristics 6 months and 1 year after surgery Comparison before/after surgery
Evaluation of environmental parameters : tobacco consumption 6 months and 1 year after surgery Comparison before/after surgery
Trial Locations
- Locations (1)
Jean Verdier Hospital
🇫🇷Bondy, France