Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT01842295
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
Study:
NCT01842295
Study Brief:
Protocol Section:
NCT01842295