Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43875   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-005145-23
    Sponsor's Protocol Code Number:53736
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-30
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-005145-23
    A.3Full title of the trial
    Prospective randomized trial comparing corifollitropin alfa (CF-alfa) late start (day 4) vs. CF-alfa standard start (day2) in poor, normal and potential high-responders undergoing IVF/ICSI
    Trial randomizzato prospettico di confronto tra protocollo di somministrazione di Corifollitropina-alfa (CF-alfa) "early start" vs. "late start" per indurre la superovulazione controllata (COS) in pazienti sottoposte a fecondazione in vitro (FIV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective randomized trial comparing corifollitropin alfa (CF-alfa) late start (day 4) vs. CF-alfa standard start (day2) in poor, normal and potential high-responders undergoing IVF/ICSI
    Trial randomizzato prospettico di confronto tra protocollo di somministrazione di Corifollitropina-alfa (CF-alfa) "early start" vs. "late start" per indurre la superovulazione controllata (COS) in pazienti sottoposte a fecondazione in vitro (FIV)
    A.3.2Name or abbreviated title of the trial where available
    ELONVA LATE START
    ELONVA LATE START
    A.4.1Sponsor's protocol code number53736
    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 SponsorDIPARTIMENTO DI SCIENZE CHIRURGICHE - UNIVERSITà DEGLI STUDI DI TORINO
    B.1.3.4CountryItaly
    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 supportUNIVERSITA' DI TORINO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi di Torino
    B.5.2Functional name of contact pointDirezione SC Ginecologia e Ostetric
    B.5.3 Address:
    B.5.3.1Street Addressvia ventimiglia 3
    B.5.3.2Town/ citytorino
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number0113135770
    B.5.5Fax number0113134405
    B.5.6E-mailchiara.benedetto@unito.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 - 150 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) - 0.5 ML 1 SIRINGA PRERIEMPITA + 1 AGO
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Italia Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameElonva
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    Women with low reproductive capacity
    donne con insufficiente capacità riproduttiva
    E.1.1.1Medical condition in easily understood language
    Women with low reproductive capacity
    donne con insufficiente capacità riproduttiva
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002658
    E.1.2Term Anovulation
    E.1.2System Organ Class 100000004860
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071102
    E.1.2Term Controlled ovarian hyperstimulation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    compare the number of retrieved oocytes in the late start CF-alfa vs. early start CF-alfa in patients undergoing IVF
    confrontare il numero di ovociti ottenuti con il protocollo di somministrazione "early start" vs. il protocollo "late start" con Corifollitropina-alfa (CF-alfa) in pazienti sottoposte a Fecondazione in vitro
    E.2.2Secondary objectives of the trial
    Compare the two protocols with regard to the oocyte morphology (assessed by polarized light microscopy) the rate of clinical pregnancy to six weeks, the incidence of side effects and the degree of satisfaction of the patient
    Confrontare i due protocolli per quanto riguarda la morfologia ovocitaria (valutata mediante microscopia a luce polarizzata) il tasso di gravidanza clinica a sei settimane, l'incidenza di effetti indesiderati e il grado di soddisfazione della paziente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-43 years
    Tubal infertility or male infertility referred for IVF
    Willingness to undergo randomization
    Età 18-43 anni
    Infertilità tubarica o maschile con indicazione alla FIV
    Volontà di sottoporsi alla randomizzazione
    E.4Principal exclusion criteria
    absence of Polycystic ovaric syndrome
    hormonal therapy in the two months preceeding IVF
    Previous ovarian hyperstimulation syndrome
    Previous superovulation controlled with excessive response
    a basalantral follicle count >20
    even benign tumors of the ovary, breast, uterus, pituitary gland or hypothalamus
    Ovaio policistico
    Terapia ormonale nei due mesi precedenti la FIV
    Pregressa sindrome da iperstimolazione ovarica
    Pregressa superovulazione controllata con risposta eccessiva
    Conta follicolare basale maggiore di 20
    Tumori anche benigni di ovaio, mammella, utero, ipofisi o ipotalamo
    E.5 End points
    E.5.1Primary end point(s)
    Number of retrieved oocytes at US guided puncture
    Numero di ovociti recuperati al prelievo ecoguidato
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Pregnancy rate with either applied protocol; Safety and undesired effects of applied protocols
    Percentuale di gravidanza ottenuta con ogni tipo di protocollo appicato; Sicurezza ed effetti collaterali dei protocolli studiati
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months; 12 months
    12 mesi; 12 mesi
    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 Yes
    E.6.5Efficacy Yes
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Modalità di somministrazione
    Administration time
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    Pregnancy test of the last enrolled patient
    Test di gravidanza dell'ultima paziente inclusa
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 110
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    None
    Nessuno
    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 Decision2017-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 17 11:46:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA