NCT01842295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2016

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

February 19, 2013

Last Update Submit

September 5, 2025

Conditions

ObesityBariatric Surgery

Keywords

ObesityBariatric surgerySperm qualityFertility

Outcome Measures

Primary Outcomes (1)

  • Number of total spermatozoids (NTS) variation

    Comparison before/after surgery

    6 months after surgery

Secondary Outcomes (10)

  • Number of total spermatozoids (NTS) variation

    1 year after surgery

  • sperm caracteristics

    6 months and 1 year after surgery

  • Effect of biological parameters on NTS variation

    6 months and 1 year after surgery

  • Evaluation of environmental parameters : physical activity

    6 months and 1 year after surgery

  • Other spermatic parameters : DNA fragmentation

    6 months and 1 year after surgery

  • +5 more secondary outcomes

Study Arms (1)

Bariatric surgery

NO INTERVENTION

Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team

Other: Blood and sperm samples

Interventions

Blood and sperm samplesOTHER

Blood and sperm samples will be done in each visit

Bariatric surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not candidates for surgery
  • With non idiopathic alteration of spermatogenesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Verdier Hospital

Bondy, 93140, France

Location

Related Publications (5)

  • Carette C, Levy R, Eustache F, Baron G, Coupaye M, Msika S, Barrat C, Cohen R, Catheline JM, Brugnon F, Slim K, Barsamian C, Chevallier JM, Bretault M, Bouillot JL, Antignac JP, Rives-Lange C, Ravaud P, Czernichow S. Changes in total sperm count after gastric bypass and sleeve gastrectomy: the BARIASPERM prospective study. Surg Obes Relat Dis. 2019 Aug;15(8):1271-1279. doi: 10.1016/j.soard.2019.04.019. Epub 2019 Apr 25.

    PMID: 31147284BACKGROUND

  • Mifsud F, Czernichow S, Carette C, Levy R, Ravaud P, Cynober L, Neveux N, Rives-Lange C; Bariasperm Study Group. Behaviour of plasma citrulline after bariatric surgery in the BARIASPERM cohort. Clin Nutr. 2021 Feb;40(2):505-510. doi: 10.1016/j.clnu.2020.05.045. Epub 2020 Jun 12.

    PMID: 32891457BACKGROUND

  • 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.

    PMID: 15618249BACKGROUND

  • 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.

    PMID: 19889752BACKGROUND

  • 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.

    PMID: 22196889BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rachel Levy, MD

    Jean Verdier Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

April 29, 2013

Study Start

February 15, 2013

Primary Completion

March 25, 2016

Study Completion

March 25, 2016

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

FR(1)