Clinical trial NCT01842295: Bariatric Surgery and Sperm Quality
Official title: Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery
Keywords: Obesity
Bariatric surgery
Sperm quality
Fertility
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of total spermatozoids (NTS) variation
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Number of total spermatozoids (NTS) variation
timeFrame: 1 year after surgery
measure: sperm caracteristics
timeFrame: 6 months and 1 year after surgery
measure: Effect of biological parameters on NTS variation
timeFrame: 6 months and 1 year after surgery
measure: Evaluation of environmental parameters : physical activity
timeFrame: 6 months and 1 year after surgery
measure: Other spermatic parameters : DNA fragmentation
timeFrame: 6 months and 1 year after surgery
measure: Other spermatic parameters : CASA
timeFrame: 6 months and 1 year after surgery
measure: Effect of anthropometric parameters on NTS variation
timeFrame: 6 months and 1 year after surgery
measure: Evaluation of environmental parameters : tobacco consumption
timeFrame: 6 months and 1 year after surgery
measure: Evaluation of environmental parameters : libido
timeFrame: 6 months and 1 year after surgery
measure: Evaluation of environmental parameters : quality of life
timeFrame: 6 months and 1 year after surgery
Other outcomes:
Locations:
city: Bondy
country: France
facility: Jean Verdier Hospital
Study officials:
affiliation: Jean Verdier Hospital
name: Rachel Levy, MD
role: STUDY_CHAIR
References:
citation: di Frega AS, Dale B, Di Matteo L, Wilding M. Secondary male factor infertility after Roux-en-Y gastric bypass for morbid obesity: case report. Hum Reprod. 2005 Apr;20(4):997-8. doi: 10.1093/humrep/deh707. Epub 2004 Dec 23.
citation: MacDonald AA, Herbison GP, Showell M, Farquhar CM. The impact of body mass index on semen parameters and reproductive hormones in human males: a systematic review with meta-analysis. Hum Reprod Update. 2010 May-Jun;16(3):293-311. doi: 10.1093/humupd/dmp047. Epub 2009 Nov 4.
citation: Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Levy R. Sperm parameters and male fertility after bariatric surgery: three case series. Reprod Biomed Online. 2012 Feb;24(2):206-10. doi: 10.1016/j.rbmo.2011.10.014. Epub 2011 Nov 3.