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    Clinical Trial Results:
    CLINICAL TRIAL, SINGLE BLIND, RANDOMIZED, CONTROLLED PROSPECTIVE EVALUATION FOR OPTIMUM TIME INTERVAL BETWEEN ACETATE ADMINISTRATION AND PUNCTURE TRIPTORELIN FOLLICULAR IN IVF TREATMENT

    Summary
    EudraCT number
    		 2012-005571-14
    Trial protocol
    		 ES  
    Global end of trial date
    02 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2022
    First version publication date
    12 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TIMING
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02244151
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Sanitaria La Fe de Valencia
    Sponsor organisation address
    Avenida Fernando Abril Martorell, Torre 106 A 7planta, 46026 València, , Valencia, Spain,
    Public contact
    UICEC , INSTITUTO DE INVESTIGACION SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    Scientific contact
    UICEC, INSTITUTO DE INVESTIGACION SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    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
    02 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Identify the optimal time interval between administration of the GnRH analogue triptorelin acetate and needle aspiration of oocytes
    Protection of trial subjects
    The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions. An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2013
    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
    Spain: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    152
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment started on 08 September 2014, and ended on 2 February 2018. A number of 131 patients were included, 127 patients completed all the study proceadures and 4 patients were excluded.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 152
    Number of subjects completed
    		 131

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 21
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 30 hours Group
    Arm description
    		 Follicular puncture 30 hours after administration of Decapeptyl®.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DECAPEPTYL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous route. Dose: 0.2 mg single dose.

    Arm title
    		 36 hours Group
    Arm description
    		 control
    Arm type
    		 Experimental

    Investigational medicinal product name
    DECAPEPTYL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous route. Dose: 0.2 mg single dose.

    Arm title
    		 40 hours group
    Arm description
    		 Follicular puncture 40 hours after administration of Decapeptyl®.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DECAPEPTYL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous route. Dose: 0.2 mg single dose.

    Arm title
    		 Not recorded
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Given the characteristics of the trial and the treatment, only the collaborating team was the one who did not know how long it was necessary to wait for the treatment until the time of making the puncture.
    Number of subjects in period 1 [2]
    		30 hours Group 36 hours Group 40 hours group Not recorded
    Started
    42
    43
    41
    5
    Completed
    40
    43
    40
    5
    Not completed
    2
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -
         Protocol deviation
    2
    -
    -
    -
    Notes
    [2] - 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: 152 patients were preselected, of which 131 were randomized, giving rise to the different groups and numbers of patients.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    30 hours Group
    Reporting group description
    		 Follicular puncture 30 hours after administration of Decapeptyl®.

    Reporting group title
    36 hours Group
    Reporting group description
    		 control

    Reporting group title
    40 hours group
    Reporting group description
    		 Follicular puncture 40 hours after administration of Decapeptyl®.

    Reporting group title
    Not recorded
    Reporting group description
    		 -

    Reporting group values
    		 30 hours Group 36 hours Group 40 hours group Not recorded Total
    Number of subjects
    		 42 43 41 5 131
    Age categorical
    Units: Subjects
        18 - 37
    		 42 43 41 5 131
    Gender categorical
    Units: Subjects
        Female
    		 42 43 41 5 131

    End points

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    End points reporting groups
    Reporting group title
    30 hours Group
    Reporting group description
    		 Follicular puncture 30 hours after administration of Decapeptyl®.

    Reporting group title
    36 hours Group
    Reporting group description
    		 control

    Reporting group title
    40 hours group
    Reporting group description
    		 Follicular puncture 40 hours after administration of Decapeptyl®.

    Reporting group title
    Not recorded
    Reporting group description
    		 -

    Primary: ovarian stimulation cycle

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    End point title
    		 ovarian stimulation cycle [1]
    End point description
    End point type
    Primary
    End point timeframe
    To determine the optimal time interval between the administration of the GnRH analog triptorelin acetate (Decapeptyl®) and the puncture-aspiration of oocytes in IVF treatments, evaluating the difference obtained in the number of mature oocytes obtained.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The research team decided that there was no significance in the 24h group, so no data was collected from it.
    End point values
    		 30 hours Group 36 hours Group 40 hours group
    Number of subjects analysed
    40
    43
    40
    Units: media
    median (standard deviation)
        Stimulation duration (days)
    9.85 ± 1.51
    10.19 ± 1.47
    10.40 ± 1.75
        Initial dose FSH (mcg)
    132.89 ± 24.04
    138.10 ± 21.55
    132.50 ± 24.15
        Total additional rFSH dose (IU)
    708.55 ± 440.76
    839.88 ± 578.53
    797.50 ± 513.56
        baseline RFA
    14.43 ± 3.71
    13.90 ± 4.13
    15.61 ± 3.33
        Number of total follicles per randomization day
    18.55 ± 7.19
    18.77 ± 5.06
    18.88 ± 5.70
        No. of follicles ≥ 16 mm day randomization
    9.30 ± 3.87
    9.67 ± 3.10
    9.70 ± 3.71
        Maximum diameter (mm)
    21.75 ± 2.68
    22.48 ± 2.12
    21.80 ± 1.96
    Statistical analysis title
    		 Kruskal-Wallis
    Comparison groups
    36 hours Group v 40 hours group v 30 hours Group
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.49
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: ESTRADIOL (pg/mL)

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    End point title
    		 ESTRADIOL (pg/mL) [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Time 0 Time 12h Time puncion
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The research team decided that there was no significance in the 24h group, so no data was collected from it.
    End point values
    		 30 hours Group 36 hours Group 40 hours group
    Number of subjects analysed
    40
    43
    40
    Units: pg/mL
    arithmetic mean (standard deviation)
        E2 Time 0
    1808.69 ± 778.60
    1838.94 ± 804.63
    2008.64 ± 937.73
        E2 Time 12h
    1914.39 ± 919.37
    2278.87 ± 860.12
    2442.41 ± 1477.59
        E2 Time P
    993.88 ± 530.63
    875.20 ± 347.84
    890.89 ± 440.11
    Statistical analysis title
    		 Kruskal-Wallis
    Comparison groups
    30 hours Group v 36 hours Group v 40 hours group
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.5
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unkown
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Non-severous
    Reporting group description
    		 -

    Serious adverse events
    		 Non-severous
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Non-severous
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Nervous system disorders
    cervical
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2015
    Protocolo and patient information sheet and informed consent changes
    28 Mar 2017
    Protocol changes

    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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