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    Clinical Trial Results:
    Prospective, open-label, uncontrolled clinical trial evaluating multiple controlled ovarian hyperstimulation cycles in oocyte donor, to assess the immunogenicity of FSH-IBSA

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2012-000269-19
    Trial protocol
    		 ES  
    Global end of trial date
    16 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Feb 2016
    First version publication date
    25 Dec 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    corrections due to software errors
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    11E/FSH03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01785095
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSA Institut Biochimique SA
    Sponsor organisation address
    via del Piano, Pambio Noranco, Switzerland,
    Public contact
    Senior Clinical Research Manager, IBSA Institute Biochimique SA, +41 583601000, barbara.cometti@ibsa.ch
    Scientific contact
    Senior Clinical Research Manager, IBSA Institut Biochimique SA, +41 583601000, barbara.cometti@ibsa.ch
    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
    17 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing COH in an oocyte donation program.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 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: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion Criteria Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Urofollitrophin
    Arm description
    		 FSH-IBSA (IBSA, Institut Biochimique SA), powder and solvent for solution for s.c. injection, supplied in vials containing 75 IU of FSH, along with prefilled syringes of solvent (physiological saline for injection)
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSH-IBSA
    Investigational medicinal product code
    Other name
    Urofollitrophin
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were instructed on FSH-IBSA self-administration and supplied with medication, with the first dose being administered by the Investigator or his/her delegate. Dosage from a minimum of75 IU and a maximum of450 IU according to subjects response.

    Number of subjects in period 1
    		Urofollitrophin
    Started
    41
    Included
    27
    Completed
    24
    Not completed
    17
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
         screening failure
    14
         treatment cancellation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Urofollitrophin
    Reporting group description
    		 FSH-IBSA (IBSA, Institut Biochimique SA), powder and solvent for solution for s.c. injection, supplied in vials containing 75 IU of FSH, along with prefilled syringes of solvent (physiological saline for injection)

    Reporting group values
    		 Urofollitrophin Total
    Number of subjects
    		 41 41
    Age categorical
    Fertile, premenopausal women
    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)
    		 41 41
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Fertile, premenopausal women.
    Units: Subjects
        Female
    		 41 41
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    All randomised subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients

    Subject analysis sets values
    		 All randomised subjects
    Number of subjects
    27
    Age categorical
    Fertile, premenopausal women
    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)
    27
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Fertile, premenopausal women.
    Units: Subjects
        Female
    27
        Male

    End points

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    End points reporting groups
    Reporting group title
    Urofollitrophin
    Reporting group description
    		 FSH-IBSA (IBSA, Institut Biochimique SA), powder and solvent for solution for s.c. injection, supplied in vials containing 75 IU of FSH, along with prefilled syringes of solvent (physiological saline for injection)

    Subject analysis set title
    All randomised subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients

    Primary: anti-FSH antibodies

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    End point title
    		 anti-FSH antibodies [1]
    End point description
    To test the production of anti-FSH antibodies (IgG, IgM, and IgA) using a sensitive screening assay.
    End point type
    Primary
    End point timeframe
    At day 1, after 6-8 days, after 28 days.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned since the end point was to assess the production of antibodies against FSH. No antibodies were detected. No statistical analysis was performed.
    End point values
    		 Urofollitrophin All randomised subjects
    Number of subjects analysed
    27
    27
    Units: presence or absence
        number (not applicable)
    27
    27
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Randomised subjects
    Reporting group description
    		 All the subjects who were randomised and had at least one FSH injection.

    Serious adverse events
    		 Randomised subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 27 (3.70%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Randomised subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 27 (25.93%)
    Injury, poisoning and procedural complications
    lymb injury
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    General disorders and administration site conditions
    pirexia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Musles spasm
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Infections and infestations
    bacteria vaginosis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    candida infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1

    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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