Bariatric Surgery and Sperm Quality

Obesity Clinical Trial

— BARIASPERM  

Official title:

Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842295
• Other study ID #: P110153
• Secondary ID: AOM11193
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: March 16, 2018
• Start date: February 15, 2013
• Est. completion date: March 25, 2016

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 25, 2016
• Est. primary completion date: March 25, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Other:
• Blood and sperm samples
Blood and sperm samples will be done in each visit

Locations

Country	Name	City	State
France	Jean Verdier Hospital	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Epub 2004 Dec 23. — View 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. Review. — View Citation

Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Lévy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of total spermatozoids (NTS) variation	Comparison before/after surgery	6 months after surgery
Secondary	Number of total spermatozoids (NTS) variation	Comparison before/after surgery	1 year after surgery
Secondary	sperm caracteristics	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Effect of biological parameters on NTS variation	Comparison before/after surgery and search of correlation	6 months and 1 year after surgery
Secondary	Evaluation of environmental parameters : physical activity	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Other spermatic parameters : DNA fragmentation	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Other spermatic parameters : CASA	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Effect of anthropometric parameters on NTS variation	Comparison before/after surgery and search of correlation	6 months and 1 year after surgery
Secondary	Evaluation of environmental parameters : tobacco consumption	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Evaluation of environmental parameters : libido	Comparison before/after surgery	6 months and 1 year after surgery
Secondary	Evaluation of environmental parameters : quality of life	Comparison before/after surgery	6 months and 1 year after surgery