Bariatric Surgery and Sperm Quality (BARIASPERM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Bariatric Surgery; Obesity

Treatments: Other: Blood and sperm samples

Study type: Interventional

Funder types: Other

Identifiers

NCT01842295

AOM11193 (Other Grant/Funding Number)

P110153

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Bariatric surgery

No Intervention group

Description:

Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team

Treatment:

Other: Blood and sperm samples