ObesitySexObNCT03528980
Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity
An observational study of Obesity and Bariatric Surgery Candidate, run by University Hospital, Lille at 3 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- How many people
- 59 participants
- Where
- 3 sitesFrance
- Study dates
- 21 May 2012to Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: patients with morbid obesity,
Who may be able to join
- Severe obesity with BMI> 25 kg / m2
Who cannot join
- Patient having undergone sterilization
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu de Caen Normandie
Caen
CHRU, Hôpital Claude Huriez
Lille
Chu Rouen
Rouen
About this study
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
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
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- fertility, bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Not described | |
| standard nutritional management | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1 year
Secondary outcomes (4)
Percentage of patients with normal sexual function (IIED> 25) with and without surgery.
Measured: ay 1 year
Change the spermatic parameters before and after weight loss in both groups
Measured: at 1 year and 2 years
Change the serum profile of sex hormones before and after weight loss in both groups a
Measured: at 1 year
Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start21 May 2012
- Primary completionJan 2019
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Robert Caiazzo, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528980
- Sponsor's protocol ID
- 2011_07
- Other IDs
- 2011-A01012-39
- Acronym
- SexOb
- Status last verified
- May 2026
- First submitted
- 25 Apr 2018
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03528980
- Acronym / sponsor ID
- SexOb / 2011_07
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- fertility, bariatric surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 21 May 2012 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2034 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | – |
| standard nutritional management | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with morbid obesity,
Key inclusion criteria (1 listed)
- Severe obesity with BMI> 25 kg / m2
Key exclusion criteria (1 listed)
- Patient having undergone sterilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED)
Time frame: at 1 year
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
4 secondary outcomes
Percentage of patients with normal sexual function (IIED> 25) with and without surgery.
Time frame: ay 1 year
Change the spermatic parameters before and after weight loss in both groups
Time frame: at 1 year and 2 years
Change the serum profile of sex hormones before and after weight loss in both groups a
Time frame: at 1 year
Correlate the spermatic profile to the different nutritional deficiencies high lighted after the bariatric surgery
Time frame: at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Caiazzo, MD, PhD principal investigator
University Hospital, Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of sexual function assessed by International Index for Erectile Dysfunction (IIED) (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.