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NCT03528980 Clinical Trial

Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity

Obesity Clinical Trial

— SexOb  

Official title:
Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03528980
Other study ID # 2011_07
Secondary ID 2011-A01012-39
Status Terminated
Phase
First received
Last updated
Start date May 2012
Est. completion date January 2021

Study information
Verified date March 2021
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity

Recruitment information / eligibility
Status Terminated
Enrollment 59
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Severe obesity with BMI> 25 kg / m2 Exclusion Criteria: - Patient having undergone sterilization

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Chu de Caen Normandie Caen
France CHRU, Hôpital Claude Huriez Lille
France Chu Rouen Rouen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED) This questionnaire consists of 15 questions addressing the following topics: erectile function, orgasmic function, sexual desire, satisfaction of the sexual relation, satisfaction of the relationship in general. Each question is scored from 0 to 5. All responses are scored between 0 and 75. Sexual function is considered normal if the IIED score is greater than 25 at 1 year
Secondary Percentage of patients with normal sexual function (IIED> 25) with and without surgery. ay 1 year
Secondary Change the spermatic parameters before and after weight loss in both groups at 1 year and 2 years
Secondary Change the serum profile of sex hormones before and after weight loss in both groups a at 1 year
Secondary Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery at 1 year
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