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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001708-39
    Sponsor's Protocol Code Number:S54224
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-04-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-001708-39
    A.3Full title of the trial
    Prospective randomized trial concerning three different stimulation methods in IVF/ICSI treatment in poor responders
    Prospectief gerandomiseerd onderzoek van drie verschillende stimulatiemethodes bij POOR RESPONDERS tijdens een IVF/ICSI behandeling.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective randomized trial concerning three different stimulation methods in IVF/ICSI treatment in poor responders
    Prospectief gerandomiseerd onderzoek van drie verschillende stimulatiemethodes bij POOR RESPONDERS tijdens een IVF/ICSI behandeling.
    A.3.2Name or abbreviated title of the trial where available
    POOR RESPONDERS
    A.4.1Sponsor's protocol code numberS54224
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital Leuven
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospital Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Leuven
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216341998
    B.5.6E-mailCTC@uzleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Elonva
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCorifollitropin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Puregon
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePuregon
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOLLITROPIN BETA
    D.3.9.1CAS number 169108-34-3
    D.3.9.4EV Substance CodeSUB12503MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subfertility
    E.1.1.1Medical condition in easily understood language
    Subfertility
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016465
    E.1.2Term Fertility female decreased
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to test the hypothesis that ovarian stimulation with Corifollitropin alfa FSH with a prolonged activity) in women who showed a poor ovarian repsonse in the previous IVF/ICSI cycle, results in a higher chance on a live birth
    Het objectief is om de hypothese te testen dat ovariële stimulatie door Corifollitropin alfa (langwerkend FSH) bij patiënten die in een vorige IVF/ICSI cyclus een poor respons vertoonden, een hogere kans op een levendgeboorte zou opleveren
    E.2.2Secondary objectives of the trial
    Pregnancy rate per IVF/ICSI cycle started in the trial
    Number of oocytes per IVF/ICSI cycle started in the trial
    Percentage of cycles withou oocyte aspiration due to abscence of ovarian repsonse
    Embryo quality (absolute number and percentage of good quality embryos)
    Zwangerschapskans per gestarte IVF/ICSI cyclus in de trial.
    Aantal eicellen per gestarte IVF/ICSI cyclus in de trial.
    Percentage cycli dat niet tot eicelaspiratie leidt wegens non- respons.
    Embryokwaliteit (absolute aantallen en percentage goede kwaliteitsembryo’s)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients <43 years old, BMI≤30 and a normal uterine cavity (demonstrated by ultrasound, hysterosalpingography, hysteroscopy) for whom an IVF/ ICSI treatment is indicated and who were 'Poor Responders' (POR) in the previous IVF/ICSI cycle, meaning that at least two of the following three features must be present:

    ≥40 years or any other risk factor for POR;
    ≤3 oocytes in the previous IVF/ICSI cycle with a conventional stimulation protocol
    an abnormal ovarian reserve test (i.e. AFC <5–7 follicles or AMH <0.5–1.1 ng/ml)
    Patiënten <43 jaar, BMI≤30 en een normale uteriene caviteit (echografie, hysterosalpingografie, hysteroscopy)
    met een indicatie voor IVF/ICSI, die in de voorgaande cyclus 'Poor Responder' (POR) waren, dwz dat minstens 2 van de volgende 3 voorwaarden vervuld moeten zijn:

    ≥40 jaar of een anderer risico factor voor POR
    ≤3 eicellen in een vorige IVF/ICSI cyclus met een conventioneel stimulatie protocol
    een abnormale ovariële reserve test (i.e. <5–7 antrale follikels of AMH <0.5–1.1 ng/ml)
    E.4Principal exclusion criteria
    Patients undergoing a treatment with Preimplantation Genetic Diagnosis or ICIS with cryo-TESE
    Patiënten die een behandeling met Preimplantie Genetische Diagnose of ICSI met cryo- TESE krijgen
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of live births per IVF/ICSI cycle started in the trial
    percentage levendgeborenen per gestarte IVF/ICSI cyclus
    E.5.1.1Timepoint(s) of evaluation of this end point
    About 9 months after the start of the IVF/ICSI cycle in case of a pregnancy
    Ongeveer 9 maanden na de start va nde IVF/ICSI cyclus in geval van zwangerschap
    E.5.2Secondary end point(s)
    Pregnancy rate per IVF/ICSI cycle in the trial
    Number of oocytes per IVF/ICSI cycle in the trial
    Percentage of cycles without oocyte aspiration due to absence of ovarian response
    Embyro quality (absolute number and percentage of good quality embryos
    Zwangerschapskans per gestarte IVF/ICSI cyclus.
    Aantal eicellen per gestarte IVF/ICSI cyclus.
    Percentage cycli dat niet tot eicelaspiratie leidt wegens non- respons.
    Embryokwaliteit (absolute aantallen en percentage goede kwaliteitsembryo’s).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The result 'pregnant/not pregnant' is determinated at maximum 8 weeks after the start of the IVF/ICIS cycle
    Number of oocyte is registered after a maximum of 22 days of ovarian stimulation
    The 'occurence/non occurence of oocyte aspiration due to the absence of ovarina response' is registered after a maximum of 22 days of ovarian stimualtion
    Embryo quality is registered until a maximum of 7 days after the oocyte aspiration
    Het resultaat 'zwanger/niet zwanger' wordt bepaald op maximum 8 weken na de start van de IVF/ICSI cyclus
    Het aantal eicellen wordt geregistreerd op maximim 22 dagen ovariële stimulatie
    Het al dan niet uitvoeren van eicelaspiratie ten gevolge van ontbreken van ovariële respons wordt geregistreerd op maximim 22 dagen ovariële stimulatie
    Embryo kwaliteit wordt geregistreerd tot maximum 7 dagen na de eicelaspiratie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Since the primary outcome is the percentage of live births, the end of the trial is identified as the date of the delivery of the last pregnant patient in the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    not applicable
    niet van toepassing
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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