Bariatric Surgery and Sperm Quality | NCT01842295

Studies
Bariatric Surgery and Sperm Quality

NCT01842295

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Sep 11, 2025Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Obesity
Bariatric Surgery

Interventions

Blood and sperm samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AOM11193	Other Grant/Funding Number	Programme Hospitalier de Recherche Clinique (PHRC)

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2013Actual

Primary Completion Date

Mar 25, 2016Actual

Completion Date

Mar 25, 2016Actual

First Submitted Date

Feb 19, 2013

First Submission Date that Met QC Criteria

Apr 24, 2013

First Posted Date

Apr 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 11, 2025Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric surgery	No Intervention	Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team	Other: Blood and sperm samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood and sperm samples	Other	Blood and sperm samples will be done in each visit	Bariatric surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Number of total spermatozoids (NTS) variation	Comparison before/after surgery	1 year after surgery
sperm caracteristics	Comparison before/after surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Levy, MD	Jean Verdier Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jean Verdier Hospital		Bondy		93140	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15618249	Background	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.
19889752	Background	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis