Overview

This trial is active, not recruiting.

Conditions obesity, bariatric surgery
Treatment blood and sperm samples
Sponsor Assistance Publique - Hôpitaux de Paris
Start date February 2013
End date March 2016
Trial size 46 participants
Trial identifier NCT01842295, AOM11193, P110153

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(No Intervention)
Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
blood and sperm samples
Blood and sperm samples will be done in each visit

Primary Outcomes

Measure
Number of total spermatozoids (NTS) variation
time frame: 6 months after surgery

Secondary Outcomes

Measure
Number of total spermatozoids (NTS) variation
time frame: 1 year after surgery
sperm caracteristics
time frame: 6 months and 1 year after surgery
Effect of biological parameters on NTS variation
time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : physical activity
time frame: 6 months and 1 year after surgery
Other spermatic parameters : DNA fragmentation
time frame: 6 months and 1 year after surgery
Other spermatic parameters : CASA
time frame: 6 months and 1 year after surgery
Effect of anthropometric parameters on NTS variation
time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : tobacco consumption
time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : libido
time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : quality of life
time frame: 6 months and 1 year after surgery

Eligibility Criteria

Male participants from 18 years up to 50 years old.

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

Additional Information

Official title Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.