Men InfertilityNCT03971786
Sperm Parameters and Sexual Quality of Life
A study testing Quality of life in people with Men Infertility, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Infertility has important repercussions for couples in their emotional and sexual lives; the same is true of Assisted Procreation, which has an impact on the daily life of couples and a cost to society. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Men Infertility
- What is being tested?
- Quality of life
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 31 Aug 2021
- Phase
- Interventional
- 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
Who may be able to join
- Male patient presenting infertility status
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
Jeanne Perrin, MD contact
About this study
Infertility has important repercussions for couples in their emotional and sexual lives; the same is true of Assisted Procreation, which has an impact on the daily life of couples and a cost to society. Thus, fertility disorders are frequently associated with sexual dysfunction in both women and men (Khademi et al., 2008). In couples with male infertility, men have higher sexual dysfunction scores than couples with infertility without male aetiology (Smith et al., 2009).
To study the evolution of the sexual quality of life of infertile men before and after knowing their spermatic parameters
- Conditions
- Men Infertility
- Being tested
- Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeBehavioural
Assessment of quality of life through measuring scales
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of quality of life scoring with Male Sexual Health scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men InfertilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971786
- Sponsor's protocol ID
- 2018-A02455-50
- Other IDs
- 2018-53
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Parameters and Sexual Quality of Life
- ClinicalTrials.gov ID
- NCT03971786
- Acronym / sponsor ID
- 2018-A02455-50
- Conditions
- Men Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 3 Jun 2019 (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.
Infertility has important repercussions for couples in their emotional and sexual lives; the same is true of Assisted Procreation, which has an impact on the daily life of couples and a cost to society. Thus, fertility disorders are frequently associated with sexual dysfunction in both women and men (Khademi et al., 2008). In couples with male infertility, men have higher sexual dysfunction scores than couples with infertility without male aetiology (Smith et al., 2009).
To study the evolution of the sexual quality of life of infertile men before and after knowing their spermatic parameters
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patient presenting infertility status
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeAssessment of quality of life through measuring scales | Behavioural | – |
Primary outcome
Variability of quality of life scoring with Male Sexual Health scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- 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.
Jeanne Perrin, MD contact
Emilie Garrido study director
Assistance Publique Hopitaux De Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life in people with Men Infertility, run by Assistance Publique Hopitaux De Marseille.
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: status not confirmed, as of the sponsor's last update on 3 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Perrin, MD (jeanne.perrin@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of quality of life scoring with Male Sexual Health scale (time frame: 12 months). 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 3 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.