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Sperm Parameters and Sexual Quality of Life

Primary Purpose

Men Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quality of life
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Men Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patient presenting infertility status

Exclusion Criteria:

  • none

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Variability of quality of life scoring with Male Sexual Health scale

    Secondary Outcome Measures

    Full Information

    First Posted
    May 31, 2019
    Last Updated
    May 31, 2019
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03971786
    Brief Title
    Sperm Parameters and Sexual Quality of Life
    Official Title
    Sperm Parameters and Sexual Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    August 31, 2020 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Men Infertility

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Quality of life
    Intervention Description
    Assessment of quality of life through measuring scales
    Primary Outcome Measure Information:
    Title
    Variability of quality of life scoring with Male Sexual Health scale
    Time Frame
    12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patient presenting infertility status Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeanne Perrin, MD
    Email
    jeanne.perrin@ap-hm.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emilie Garrido
    Organizational Affiliation
    Assistance Publique Hopitaux De Marseille
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Sperm Parameters and Sexual Quality of Life

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