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    Summary
    EudraCT Number:2011-003080-30
    Sponsor's Protocol Code Number:CT2011-001
    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:2011-12-29
    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 number2011-003080-30
    A.3Full title of the trial
    WEIGHT-ADJUSTED LOW MOLECOLAR WEIGHT HEPARIN IN RECURRENT IMPLANTATION FAILURE: A RANDOMIZED OPEN LABELED TRIAL
    Eparina a basso Peso Molecolare a dosaggio aggiustato per il peso corporeo in fallimenti recidivanti di impianto: studio randomizzato in aperto Eparina a basso Peso Molecolare a dosaggio aggiustato per il peso corporeo in fallimenti recidivanti di impianto: studio randomizzato in aperto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of low molecular weight heparin in improving fertility in women with previous failures in fertility procedures
    Efficacia dell'eparina a basso peso molecolare nel favorire le gravidanze in donne infertili con precedenti fallimenti di procedure di fertilizzazione
    A.4.1Sponsor's protocol code numberCT2011-001
    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 SponsorISTITUTO CLINICO HUMANITAS
    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 supportAlfa Wassermann
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Clinico Humanitas
    B.5.2Functional name of contact pointCentro Trombosi
    B.5.3 Address:
    B.5.3.1Street Addressvia Manzoni 56
    B.5.3.2Town/ cityRozzano
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02/82244602
    B.5.5Fax number+39 02/82244691
    B.5.6E-mailcorrado.lodigiani@humanitas.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 FLUXUM*SC 6SIR 0,4ML 4250UIaxa
    D.2.1.1.2Name of the Marketing Authorisation holderALFA WASSERMANN SpA
    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.3.4Pharmaceutical 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 INNPARNAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB12197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit anti-Xa IU anti-Xa activity International Unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6400
    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 Yes
    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
    Infertile patients with at least three failed assisted reproductive tecniques
    Pazienti infertili con almeno tre tentativi falliti di procedure di fertilizzazione assistita
    E.1.1.1Medical condition in easily understood language
    Infertile patients with at least three failed assisted reproductive tecniques
    Pazienti infertili con almeno tre tentativi falliti di procedure di fertilizzazione assistita
    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 SOC
    E.1.2Classification code 10036585
    E.1.2Term Pregnancy, puerperium and perinatal conditions
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration.
    Valutare efficacia dell'eparina a basso peso molecolare nel favorire il successo delle tecniche di fertilizzazione assistita in donne infertili con almeno tre precedenti tentativi falliti
    E.2.2Secondary objectives of the trial
    To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH
    Valutare il ruolo della trombofilia nella incidenza di gravidanza clinica in donne infertili con almeno tre precedenti tentativi falliti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Women, 36-40 years •At least 6 good quality embryos transferred in 3 or more previous IVF/ICSI cycles without signs of implantation. •A normal response with at least 6 oocytes retrieved with standard induction protocol. •Total progressive motile count of at least 1.000.000 sperms/eiaculate. •No testicular or frozen sperms. •Normal uterine cavity as shown by SIS or ISC. •FSH < 10 mUI/ml. •AMH ≥ 1.0 ng./ml. •No hormonal, or immunological disorders detected •No APA or other severe thrombophilia detected •Normal female and male peripheral karyotype
    eta' 36 - 40 almeno tre precedenti cicli di IVF/ICSI falliti con trasferimento di almeno 6 embrioni di buona qualita' assenza malattie ormonali immunologiche o di anticorpi antifosfolipidi o trombofilia severa cariotipo periferico femminile e maschile normale, una conta di almeno 1000000 di spermatozoi mobili per eiaculato. non utilizzare sperma direttamente prelevato dal testicolo o congelato. normale cavita' uterina studiata mediante ecografia o isteroscopia. FSH &lt; 10 mUI/ml. AMH ≥ 1.0 ng./ml.
    E.4Principal exclusion criteria
    •Age <36 years or >40 years •Less than 3 previous IVF/ICSI cycles without signs of implantation •Total progressive motile count < than 1.000.000 sperms/eiaculate. • Testicular or frozen sperms. • Previous surgery for miomas and / or endometriosis. • Clinical or ultrasound diagnosis of endometriosis. • Patients treated in previous cycles with LMWH. • Hormonal, or immunological disorders detected • FSH < 10 mUI/ml or autoantibody positivity. • APA positivity or other severe thrombophilia
    Eta' inferiore a 36 e maggiore di 40 anni. meno di tre precedenti inefficaci IVF/ICSI, precedenti PMA con eparina a basso peso molecolare, FSH &lt; 10 mUI/ml, una conta inferiore a 1000000 di spermatozoi mobili per eiaculato. utilizzo di sperma direttamente prelevato dal testicolo o congelato. assenza di una normale cavita' uterina studiata mediante ecografia o isteroscopia.presenza di trombofilia severa, anticorpi antifosfolipidi. presenza di malattie immunologiche concomitanti
    E.5 End points
    E.5.1Primary end point(s)
    The aim of the study is to evaluate the pregnancy rate in patients with repeated implantation failures undergoing a new ART cycle with or without LMWH administration.
    Valutare efficacia dell'eparina a basso peso molecolare nel favorire il successo delle tecniche di fertilizzazione assistita in donne infertili con almeno tre precedenti tentativi falliti
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 weeks
    20 settimane
    E.5.2Secondary end point(s)
    To evaluate the thrombophilic factor’s role in the clinical pregnancy rate in patients with at least three repeated implantation failures undergoing assisted reproductive techniques (ART) treated with or without weight adjusted LMWH
    Valutare il ruolo della trombofilia nella incidenza di gravidanza clinica in donne infertili con almeno tre precedenti tentativi falliti
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 weeks
    20 settimane
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nulla
    nothing
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    last patient last visit
    ultima visita ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 240
    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 Yes
    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 state240
    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)
    Follow up patients will end at the delivery and post partum
    Le pazienti verranno seguite fino al termine della gravidanza e del puerperio
    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 Decision2011-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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