FertilityFIVESNCT02759705
Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
An observational study of Fertility, run by Hospices Civils de Lyon.
Trial summary
This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Fertility
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients born with classic bladder exstrophy or epipadias
Who may be able to join
- Patients followed the Hospices Civils de Lyon
- Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology
- Aged over 18 years
- Born with classic bladder exstrophy or epispadias.
Who cannot join
- Refusal of participation
- Refusal to sign consent
- minor Patients or protected major, under guardianship
- Patients unable to understand the course of the study
- cloacal exstrophy
About this study
Official title: Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?
This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.
- Conditions
- Fertility
- Keywords
- fertility, sexuality, male, exstrophy-epispadias complex, bladder exstrophy, epispadias
- Medical subject headings
- Sexuality, Bladder Exstrophy, Epispadias
What is being measured
The primary outcome is the main question the study is designed to answer.
paternity rate
paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses
Measured: Baseline (at first consultation)
Sperm quality
concentration of mobile live sperm in semen analysis
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: no staff available to do the research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne TERRIER, Doctor, Principal investigator, Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759705
- Sponsor's protocol ID
- 69HCL16_0044
- Acronym
- FIVES
- Status last verified
- Mar 2019
- First submitted
- 28 Apr 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?
- ClinicalTrials.gov ID
- NCT02759705
- Acronym / sponsor ID
- FIVES / 69HCL16_0044
- Conditions
- Fertility
- Keywords
- fertility, sexuality, male, exstrophy-epispadias complex, bladder exstrophy, epispadias
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no staff available to do the research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 3 May 2016 (estimated)
- 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.
This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients born with classic bladder exstrophy or epipadias
Key inclusion criteria (4 listed)
- Patients followed the Hospices Civils de Lyon
- Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology
- Aged over 18 years
- Born with classic bladder exstrophy or epispadias.
Key exclusion criteria (5 listed)
- Refusal of participation
- Refusal to sign consent
- minor Patients or protected major, under guardianship
- Patients unable to understand the course of the study
- cloacal exstrophy
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
paternity rate
Time frame: Baseline (at first consultation)
paternity rate measured by the ratio of the number of subjects with children to the total number of subjects estimated with questionnaire responses
Sperm quality
Time frame: up to 2 months
concentration of mobile live sperm in semen analysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Jean-Etienne TERRIER, Doctor principal investigator
Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by Hospices Civils de Lyon.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
paternity rate (time frame: Baseline (at first consultation)). The study lists 2 primary outcomes in all. 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 13 Mar 2019.