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    Clinical Trial Results:
    Efficacy of Dehydroepiandrosterone to overcome the effect of ovarian aging

    Summary
    EudraCT number
    2011-002425-21
    Trial protocol
    GB  
    Global end of trial date
    04 Jan 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Mar 2019
    First version publication date
    01 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    11054
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    University Park, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Bruce Campbell, University of Nottingham, 0044 01158230688, bruce.campbell@nottingham.ac.uk
    Scientific contact
    Bruce Campbell, University of Nottingham, 0044 01158230688, bruce.campbell@nottingham.ac.uk
    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
    04 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To examine whether supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases the number of oocytes retrieved and the clinical pregnancy rates following IVF/ICSI treatment. • To evaluate the feasibility of conducting a large multicentre randomised controlled trial of DHEA versus Placebo in women affected with ovarian ageing undergoing IVF/ICSI treatment.
    Protection of trial subjects
    Participants were encouraged to report if any side-effects/ issues related to trial medications. They were given relevant contact details.
    Background therapy
    IVF treatment
    Evidence for comparator
    Placebo with inactive ingredients used
    Actual start date of recruitment
    01 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Age stratified randomisation was performed by computer-based random permuted block randomisation, created by the University of Nottingham Clinical Trials Unit (CTU). They were randomised to receive either capsules of 75 mg DHEA or placebo taken orally once daily for at least 12 weeks before and during controlled ovarian stimulation until the day be

    Pre-assignment
    Screening details
    Women aged more than 23 years, who were predicted to have diminished ovarian reserved determined by antral follicle count scan less than 10 and/or serum Anti-Mullerian hormone less than 5 pmol/L undertaking either IVF or ICSI treatment at the clinic, were asked to participate in the study at the time of their initial consultation. Patients had to h

    Period 1
    Period 1 title
    Baseline period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Assessor, Subject, Investigator
    Blinding implementation details
    Participants were issued their trial number as well as randomisation number and were issued their corresponding IMPs supply from the unblinded pharmacist according to the randomisation. They were randomised to receive either capsules of 75 mg DHEA or placebo, which looks exactly similar to the study medication

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Study
    Arm description
    Those who received capsules of 75 mg DHEA
    Arm type
    Experimental

    Investigational medicinal product name
    DHEA
    Investigational medicinal product code
    35929
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg once daily

    Arm title
    control
    Arm description
    received placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    one capsule daily

    Number of subjects in period 1 [1]
    Study control
    Started
    27
    25
    Completed
    27
    25
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A few subjects did not start treatment due to personal reasons/ pregnancy

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study
    Reporting group description
    Those who received capsules of 75 mg DHEA

    Reporting group title
    control
    Reporting group description
    received placebo

    Reporting group values
    Study control Total
    Number of subjects
    27 25 52
    Age categorical
    Women's age at the recruitment stage recorded
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    mean age recorded
    Units: years
        geometric mean (standard deviation)
    36.8 ± 3.9 35.2 ± 5.3 -
    Gender categorical
    Units: Subjects
        Female
    27 25 52
        Male
    0 0 0
    Cause of subfertility
    cause of subfertility
    Units: Subjects
        endometriosis
    4 5 9
        male factor
    2 5 7
        Oligo-ovulation
    2 0 2
        Tubal factor
    1 5 6
        low ovarian reserve
    5 5 10
        Unknown
    13 5 18

    End points

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    End points reporting groups
    Reporting group title
    Study
    Reporting group description
    Those who received capsules of 75 mg DHEA

    Reporting group title
    control
    Reporting group description
    received placebo

    Primary: Live birth

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    End point title
    Live birth
    End point description
    number of Live born babies after IVF treatment
    End point type
    Primary
    End point timeframe
    Nine months
    End point values
    Study control
    Number of subjects analysed
    27
    25
    Units: numbers
    7
    8
    Statistical analysis title
    Relative risk
    Statistical analysis description
    Differences in proportional outcome analysed using relative risk
    Comparison groups
    Study v control
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.63 [1]
    Method
    Chi-squared corrected
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.22
         upper limit
    2.48
    Notes
    [1] - not significant

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during treatment and unto 9 months after
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    study and control
    Reporting group description
    Whole study population

    Serious adverse events
    study and control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    study and control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: the adverse events reported are directly related to IVF treatment rather than due to trial medication or placebo

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28934714
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