Bariatric Surgery and Sperm Quality (BARIASPERM)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Jean Verdier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Bariatric surgery
Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
Other: Blood and sperm samples
Blood and sperm samples will be done in each visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of total spermatozoids (NTS) variation
Time Frame: 6 months after surgery
Comparison before/after surgery
6 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Study Chair: Rachel Levy, MD, Jean Verdier Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2013

Primary Completion (Actual)

March 25, 2016

Study Completion (Actual)

March 25, 2016

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimated)

April 29, 2013

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110153
  • AOM11193 (Other Grant/Funding Number: Programme Hospitalier de Recherche Clinique (PHRC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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