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    Clinical Trial Results:
    FITMI - First In Treating Male Infertility

    Summary
    EudraCT number
    		 2021-003451-42
    Trial protocol
    		 DK  
    Global end of trial date
    22 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2025
    First version publication date
    12 Nov 2025
    Other versions
    Summary report(s)
    		 Trial results published

    Trial information

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    Trial identification
    Sponsor protocol code
    19642021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept. Growth and Reproduction
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen , Denmark,
    Public contact
    Sekretariatet, Dept. of Growth and Reproduction, fitmi.rigshospitalet@regionh.dk
    Scientific contact
    Sekretariatet, Dept. of Growth and Reproduction, fitmi.rigshospitalet@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The aim of this intervention is to investigate whether Denosumab can improve semen quality in a sub-group of infertile men.
    Protection of trial subjects
    Calcium and vitamin D to avoid hypocalcemia
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 181
    Worldwide total number of subjects
    181
    EEA total number of subjects
    181
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    181
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From andrological clinic at growth and reproduction, RH Denmark

    Pre-assignment
    Screening details
    		 Some were referred for infertility

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Denosumab
    Arm description
    		 60 mg sc once
    Arm type
    		 Experimental

    Investigational medicinal product name
    denosumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    60 mg sc

    Arm title
    		 placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Nacl saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 mL

    Number of subjects in period 1
    		Denosumab placebo
    Started
    91
    90
    Completed
    85
    85
    Not completed
    6
    5
         Lost to follow-up
    6
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 181 181
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 181 181
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.0 ( 4.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 181 181

    End points

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    End points reporting groups
    Reporting group title
    Denosumab
    Reporting group description
    		 60 mg sc once

    Reporting group title
    placebo
    Reporting group description
    		 -

    Primary: Sperm concentration

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    End point title
    		 Sperm concentration
    End point description
    End point type
    Primary
    End point timeframe
    80 days
    End point values
    		 Denosumab placebo
    Number of subjects analysed
    85
    85
    Units: million/mL
        median (inter-quartile range (Q1-Q3))
    11 (6.7 to 18)
    12 (6.8 to 20.3)
    Statistical analysis title
    		 Ancova
    Comparison groups
    Denosumab v placebo
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    180 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Denosumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Denosumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 90 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Denosumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 91 (16.48%)
    14 / 90 (15.56%)
    Infections and infestations
    Infection
         subjects affected / exposed
    15 / 91 (16.48%)
    14 / 90 (15.56%)
         occurrences all number
    15
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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