NCT03528980

Brief 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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
90mo left

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

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 Progress66%
May 2012Jan 2034

Study Start

First participant enrolled

May 21, 2012

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2034

Expected
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

6.6 years

First QC Date

April 25, 2018

Last Update Submit

May 13, 2026

Conditions

ObesityBariatric Surgery Candidate

Keywords

fertilitybariatric surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Percentage of patients with normal sexual function (IIED> 25) with and without surgery.

    ay 1 year

  • Change the spermatic parameters before and after weight loss in both groups

    at 1 year and 2 years

  • Change the serum profile of sex hormones before and after weight loss in both groups a

    at 1 year

  • Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery

    at 1 year

Study Arms (2)

Bariatric surgery

standard nutritional management

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with morbid obesity,

You may qualify if:

  • Severe obesity with BMI\> 25 kg / m2

You may not qualify if:

  • Patient having undergone sterilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chu de Caen Normandie

Caen, France

Location

CHRU, Hôpital Claude Huriez

Lille, France

Location

Chu Rouen

Rouen, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Caiazzo, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 18, 2018

Study Start

May 21, 2012

Primary Completion

January 1, 2019

Study Completion (Estimated)

January 1, 2034

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)