Skip to main content
OpenTrials
Completed

NCT Number: NCT01842295

Bariatric Surgery and Sperm Quality

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jean Verdier Hospital

Bondy, 93140, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and sperm samples

Other

Blood and sperm samples will be done in each visit

Primary outcomes

  1. Number of total spermatozoids (NTS) variation

    Time frame: 6 months after surgery

    Comparison before/after surgery

Secondary outcomes

  1. Number of total spermatozoids (NTS) variation

    Time frame: 1 year after surgery

    Comparison before/after surgery

  2. sperm caracteristics

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  3. Effect of biological parameters on NTS variation

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery and search of correlation

  4. Evaluation of environmental parameters : physical activity

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  5. Other spermatic parameters : DNA fragmentation

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  6. Other spermatic parameters : CASA

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  7. Effect of anthropometric parameters on NTS variation

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery and search of correlation

  8. Evaluation of environmental parameters : tobacco consumption

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  9. Evaluation of environmental parameters : libido

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

  10. Evaluation of environmental parameters : quality of life

    Time frame: 6 months and 1 year after surgery

    Comparison before/after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: BARIASPERM

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2013
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.