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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2013-002482-19
    Sponsor's Protocol Code Number:13EU/FSH01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-03
    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 number2013-002482-19
    A.3Full title of the trial
    Randomised clinical trial comparing highly purified FSH formulation (Fostimon®) and recombinant FSH (Gonal-F®) in GnRH-antagonist controlled ovarian hyperstimulation cycles
    Gerandomiseerde klinische studie ter vergelijking van de in hoge mate gezuiverde FSH-formulering (Fostimon®) met recombinant FSH (Gonal F®) bij ovariële hyperstimulatiecycli gecontroleerd met een GnRH-antagonist.
    Essai clinique randomisé visant à comparer une formulation de FSH hautement purifiée (Fostimon®) à une formulation de FSH recombinante (Gonal-F®) dans le cadre de cycles d'hyperstimulation ovarienne contrôlée par un antagoniste de la GnRH.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of two types of follicle stimulating hormone (FSH)
    formulations during fertility treatment
    A.3.2Name or abbreviated title of the trial where available
    A comparison of two FSH formulations (Fostimon® and Gonal-F®) in ovarian hyperstimulation during IVF
    A.4.1Sponsor's protocol code number13EU/FSH01
    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 SponsorIBSA, Institut Biochimique S.A.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIBSA Institut Biochimique S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLB Research srl
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia, 81
    B.5.3.2Town/ cityCantù
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number0039031734908
    B.5.5Fax number00390317372218
    B.5.6E-maillaura.rinaldi@lbresearch.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 Fostimon
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA Farmaceutici Italia Srl
    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 nameFostimon
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    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 INNUROFOLLITROPIN
    D.3.9.1CAS number 97048-13-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameUROFOLLITROPIN
    D.3.9.4EV Substance CodeSUB05053MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to 450
    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.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 Gonal-F
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGonal-F
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    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 ALPHA
    D.3.9.1CAS number 146479-72-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA (GENETICAL RECOMBINATION)
    D.3.9.4EV Substance CodeSUB126817
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 450
    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 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
    female infertility
    onvruchtbaarheid bij vrouwen
    l'infertilité féminine
    E.1.1.1Medical condition in easily understood language
    women submitted to assisted reproductive techology (ART) requiring ovaries stimulation
    Vrouwen die ovariële stimulatie ondergaan voor ivf
    Femmes sous stimulation ovarienne en vue d'une FIV
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon®, IBSA Institut Biochimique SA versus Gonal-F®) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle
    Het doel van de niet-inferioriteitsstudie is de evaluatie van de klinische werkzaamheid en veiligheid van twee verschillende subcutane FSH-preparaten (Fostimon® versus Gonal-F®) voor gecontroleerde ovariële hyperstimulatie in een cyclus met een GnRH-antagonist
    Cette étude de non-infériorité a pour but d'évaluer l'efficacité et l'innocuité cliniques de deux préparations de FSH sous-cutanées (Fostimon versus Gonal-F®) destinées à l'hyperstimulation ovarienne contrôlée dans le cadre d'un cycle impliquant l'administration d'un antagoniste de la GnRH.
    E.2.2Secondary objectives of the trial
    1) Ovarian stimulation
    2) Oocyte quality
    3) Embryo quality
    4) Final result
    1) Ovariële stimulatie
    2) Kwaliteit van oöcyten
    3) Kwaliteit van het embryo
    4) Eindresultaat
    1) Stimulation ovarienne
    2) Qualité des ovocytes
    3) Qualité des embryons
    4) Résultat final
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule;
    -> =18 and <39 years old;
    -BMI: > =18 and < =28 kg/m2;
    -Less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery);
    -Basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
    -TSH < 2.5 mIU/L
    ->10 and <30 antral follicles 2-10 mm in size for both ovaries combined (measured day 2-4 of menstrual cycle)
    -AMH > 1 ng/ml (7.15 pmol/l) and < 5.6 ng/ml (40 pmol/l)
    -Presence and adequate visualisation of both ovaries;
    -Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or
    hysteroscopic examination.
    - In staat zijn en bereid zijn het toestemmingsformulier voor patiënten te ondertekenen en het bezoekschema voor de studie na te leven;
    - ≥18 jaar en < 39 jaar oud zijn;
    - BMI: > = 18 en < =28 kg/m²;
    - Minder dan 3 voorafgaande ivf-cycli voltooid hebben (een voltooide cyclus = oogsten van eicellen);
    - Basaal FSH < 10 IE/l en E2 < 80 pg/ml (~290 pmol/l);
    - TSH < 2,5 mIE/l;
    - > 10 en < 30 antrale follikels met een grootte van 2-10 mm voor beide ovaria samen (gemeten op dag 2-4 van de menstruatiecyclus);
    - AMH: > 1 ng/ml (7,15 pmol/l) en < 5,6 ng/ml (40 pmol/l);
    - Aanwezigheid en toereikende visualisatie van beide ovaria;
    - Een baarmoederholte die in de 12 maanden vóór aanvang van de studie overeenstemt met de verwachte normale functie, beoordeeld met transvaginale echografie, hysterosalpingogram, sonohysterogram of een hysteroscopisch onderzoek.
    - Capables de et disposées à signer le Formulaire de Consentement de la Patiente et se conformer au planning des consultations liées à l'étude ;
    - Âgées de ≥18 à < 39 ans ;
    - IMC : entre > =18 et < =28 kg/m² ;
    - Ayant subi moins de 3 cycles de FIV complets (c.-à-d. un cycle complet = récupération d'ovules) ;
    - Taux basal de FSH < 10 UI/l et taux d'E2 < 80 pg/ml (~290 pmol/l) ;
    - Taux de TSH < 2,5 mUI/l
    - > 10 et < 30 follicules antraux de 2-10 mm pour les deux ovaires combinés (mesurés entre le 2e et le 4e jour du cycle menstruel)
    - Taux d'AMH : > 1 ng/ml (7,15 pmol/l) et < 5,6 ng/ml (40 pmol/l)
    - Présence et bonne visualisation des deux ovaires ;
    - Dans les 12 mois précédant le début de l'étude, cavité utérine présentant un fonctionnement normal selon les résultats de l'échographie transvaginale, de l'hystérosalpingographie, de la sonohystérographie ou de l'examen hystéroscopique
    E.4Principal exclusion criteria
    - Age <18 and 39 years;
    - Primary ovarian failure or women known as poor responders (according to the Bologna criteria1);
    - PCO & PCOS (according to Rotterdam criteria2);
    - Severe OHSS in a previous COH cycle;
    - Uterine malformation that may impair the possibility to get pregnant;
    - Ovarian cysts >10 mm;
    - Hydrosalpinx that have not been surgically removed or ligated;
    - Endometriosis stage 3 or 4;
    - Oocyte donation;
    - Severe male factor (partner, with semen collected surgically because not able to ejaculate or, if able, no sperms present and the sperms must be recovered surgically from the epididymis);
    - Patients affected by pathologies associated with any contraindication of being pregnant;
    - History of recurrent miscarriage (i.e. more than 3 previous miscarriages);
    - Hypersensitivity to the study medication;
    - Abnormal bleeding of undetermined origin;
    - Uncontrolled thyroid or adrenal dysfunction;
    - Neoplasias;
    - Severe impairment of renal and/or hepatic function;
    - Use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents).
    - Porphyria;
    - A history of, or current deep vein thrombosis, thrombophlebitis or thromboembolic disorders; thrombogenic valvulopathies or thrombogenic rhythm disorders;
    - Hereditary or acquired predisposition for venous or arterial thrombosis;
    - Idiopathic jaundice;
    - Severe pruritus;
    - Cerebrovascular or coronary artery disease;
    - Diabetes with vascular involvement;
    - Ophthalmic pathology of vascular origin
    - Headaches with focal neurological symptoms (such as aura) including hemiplegic migraine;
    - Uncontrolled hypertension;
    - Pancreatitis associated with severe hypertriglyceridaemia (current or history);
    - Concomitant use of Ritonavir.
    - Leeftijd < 18 jaar en  39 jaar;
    - Primair ovarieel falen of vrouwen van wie bekend is dat ze ontoereikend reageren (conform de Bologna-criteria1);
    - PCO en PCOS (conform de Rotterdam-criteria2);
    - Ernstig OHSS in een eerdere cyclus van gecontroleerde ovariële hyperstimulatie;
    - Uterusmisvorming die mogelijk de kans op zwangerschap belemmert;
    - Ovariumcysten > 10 mm;
    - Hydrosalpinx die niet chirurgisch is verwijderd of afgebonden;
    - Endometriose stadium 3 of 4;
    - Donatie van oöcyten;
    - Ernstige mannelijke factor (partner, met chirurgisch verzameld sperma omdat deze partner niet in staat is te ejaculeren of, indien wel in staat, er geen zaadcellen aanwezig zijn en de zaadcellen operatief moeten teruggevorderd vanuit de epididymis);
    - Patiënten die pathologieën hebben die verband houden met een contra-indicatie voor een zwangerschap;
    - Voorgeschiedenis van recidiverende miskraam (d.w.z. meer dan 3 eerdere miskramen);
    - Overgevoeligheid voor de studiemedicatie;
    - Abnormale bloeding van onbekende oorsprong;
    - Schildklier- of bijnierdisfunctie die niet onder controle is;
    - Neoplasieën;
    - Ernstige nier- en/of leverfunctiestoornis;
    - Gebruik van gelijktijdige medicatie die de studie-evaluaties zou kunnen hinderen (bv. hormonale medicatie die niet tot de studie behoort, prostaglandineremmers, psychotropica);
    - Porfyrie;
    - Een voorgeschiedenis van, of huidige diepe veneuze trombose, tromboflebitis of trombo-embolische aandoeningen; trombogeen valvulopathies of thrombogene hartritmestoornissen;
    - Erfelijke of verworven predispositie voor veneuze of arteriële trombose;
    - Idiopathische geelzucht;
    - Ernstige jeuk;
    - Cerebrovasculair of coronair vaatlijden;
    - Diabetes met vasculaire symptomen;
    - Oogheelkundige pathologie van vasculaire oorsprong
    - Hoofdpijn met focale neurologische symptomen (zoals aura) inclusief hemiplegische migraine;
    - Ongecontroleerde hypertensie;
    - Pancreatitis geassocieerd met ernstige hypertriglyceridemie (huidige of voogeschiedenis);
    - Gelijktijdig gebruik van Ritonavir.
    - Âgées de < 18 ans et de 39 ans ;
    - Femmes présentant une insuffisance ovarienne primaire ou considérées comme étant des mauvaises répondeuses (conformément aux critères de Bologne1) ;
    - OPK & SOPK (conformément aux critères de Rotterdam2) ;
    - SHO grave dans le cadre d'un précédent cycle de HOC ;
    - Malformation utérine pouvant altérer la capacité à tomber enceinte ;
    - Kystes ovariens >10 mm ;
    - Hydrosalpinx n'ayant pas été retiré ou ligaturé chirurgicalement ;
    - Endométriose de stade 3 ou 4 ;
    - Don d'ovocytes ;
    - Facteur masculin sévère (partenaire dont le sperme est recueilli chirurgicalement parce qu'incapable d’éjaculer ou, si capable d'éjaculer, absence de spermatozoïdes, et nécessité de prélever les spermatozoïdes chirurgicalement dans l’epididyme.
    - Patientes souffrant de pathologies contre-indiquant toute grossesse ;
    - Antécédents de fausses couches récurrentes (c.-à-d. plus de 3 fausses couches) ;
    - Hypersensibilité au médicament à l'étude ;
    - Saignement anormal d'origine indéterminée ;
    - Dysfonctionnement thyroïdien ou surrénalien non contrôlé ;
    - Néoplasies ;
    - Altération sévère de la fonction rénale et/ou hépatique ;
    - Utilisation de médicaments concomitants pouvant interférer avec les évaluations liées à l'étude (par ex. médicaments hormonaux n'étant pas administrés dans le cadre de l'étude, inhibiteurs de la prostaglandine, agents psychotropes)
    - Porphyrie ;
    - Antécédent de, ou présence actuellement d'une thrombose veineuse profonde, d'une thrombophlébite ou d'un trouble thromboembolique ;
    - Prédisposition héréditaire ou acquise pour une thrombose veineuse ou artérielle ;
    - Ictère idiopathique ;
    - Prurit sévère ;
    - Maladie des artères coronariennes ou maladie cérébrale vasculaire ;
    - Diabète avec implication vasculaire ;
    - Pathologie ophtalmique d’origine vasculaire ;
    - Maux de tête avec des symptômes focaux neurologiques (par exemple aura), y inclus la migraine hémiplégique ;
    - L’hypertension incontrôlée ;
    - La pancréatite associée à une hyper triglycéridémie sévère (en cours ou passée) ;
    - L’usage concomitant de Ritonavir.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer. A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation.
    Percentage van klinische zwangerschap, per gestimuleerde cyclus, per oogst van oöcyten en per embryotransfer. Een klinische zwangerschap wordt gedefinieerd als een zwangerschap waarbij met een echografie hartactiviteit van het embryo wordt aangetoond na 8 weken zwangerschap.
    Taux de grossesse clinique, par cycle stimulé, par prélèvement d'ovocytes et par transfert d'embryons. Une grossesse clinique est définie comme une grossesse présentant à l'échographie une activité cardiaque embryonnaire à 8 semaines de gestation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8 of pregnancy
    8 weken zwangerschap
    8 semaines de gestation
    E.5.2Secondary end point(s)
    1) Ovarian stimulation
    • Mean FSH dose (daily and total);
    • Number of days of FSH stimulation;
    • Number of follicles >16 mm on the day of hCG injection;
    • Progesterone and 17 beta-estradiol levels on the day of hCG triggering;
    • Cancellation rate with reasons.
    2) Oocyte quality
    • Total number of oocytes retrieved;
    • Mean number of mature oocytes (grade III-metaphase II) and ratio MII/Total oocytes retrieved;
    • Mean number of immature oocytes and ration Immature/total oocytes retrieved;
    • Mean number inseminated/injected oocytes;
    • Fertilization rate: defined as the number of 2PN (or already cleaved) embryos on Day 1 divided by the total number of injected/ inseminated oocytes;
    • Cleavage rate: defined as the number of cleaved embryos on culture day 2 divided by the total number of injected/inseminated oocytes.
    3) Embryo quality
    • Total number of embryos obtained, plus number transferred and frozen;
    • Embryo quality: assessment of blastomeres number and embryo morphology parameters: degree of fragmentation and cell division aspect.
    4) Final result
    • Positive beta-hCG test per oocyte retrieval and per embryo transfer;
    • Implantation rate, defined as the ratio of the number of implanted embryos (presence of gestational sac assessed by ultrasound) and the number of transferred embryos.
    Ovariële stimulatie
    • Gemiddelde FSH-dosis (dagelijks en in totaal);
    • Aantal dagen van FSH-stimulatie;
    • Aantal follikels > 16 mm op de dag van hCG-injectie;
    • Progesteron- en 17 beta-oestradiolspiegels op de dag waarop hCG wordt toegediend;
    • Percentage voor annuleringen met een reden.
    Kwaliteit van oöcyten
    • Totaal aantal geoogste oöcyten;
    • Gemiddeld aantal rijpe oöcyten (graad III-metafase II) en verhouding MII/totaal aantal geoogste oöcyten;
    • Gemiddeld aantal onrijpe oöcyten en verhouding onrijpe/totaal aantal geoogste oöcyten;
    • Aantal geoogste oöcyten per gebruikte eenheden van het geneesmiddel;
    • Gemiddeld aantal geïnsemineerde/geïnjecteerde oöcyten;
    • Fertilisatiepercentage;
    • Splitsingspercentage.
    Kwaliteit van het embryo
    • Totaal aantal verkregen embryo’s, plus aantal embryotransfers en ingevroren embryo’s;
    • Kwaliteit van het embryo.
    Eindresultaat
    • Positieve beta-hCG-test per geoogste oöcyt en per embryotransfer;
    • Implantatiepercentage, gedefinieerd als de verhouding van het aantal geïmplanteerde embryo’s (aanwezigheid van vruchtzak, geëvalueerd met een echografie) en het aantal embryotransfers.
    Stimulation ovarienne
    • Dose moyenne de FSH (quotidienne et totale) ;
    • Nombre de jours de stimulation par FSH ;
    • Nombre de follicules > 16 mm le jour de l'injection de hCG ;
    • Taux de progestérone et de 17 beta-œstradiol le jour du déclenchement par hCG ;
    • Taux d'annulation avec raisons.
    Qualité des ovocytes
    • Nombre total d'ovocytes prélevés ;
    • Nombre moyen d'ovocytes (grade III-métaphase II) et ratio MII/total d'ovocytes prélevés ;
    • Nombre moyen d'ovocytes immatures et ratio ovocytes immatures/total d'ovocytes prélevés ;
    • Nombre d'ovocytes prélevés par unités de médicament utilisés ;
    • Nombre moyen d'ovocytes inséminés/injectés ;
    • Taux de fécondation ;
    • Taux de clivage.
    Qualité des embryons
    • Nombre total d'embryons obtenus plus nombre d'embryons transférés et congelés ;
    • Qualité des embryons.
    Résultat final
    • Test beta-hCG positif par prélèvement d'ovocytes et par transfert d'embryons ;
    • Taux d'implantation, défini comme le ratio entre le nombre d'embryons implantés (présence d'un sac gestationnel vérifiée à l'échographie) et le nombre d'embryons transférés
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ovarian stimulation: Visit 4 (induction of ovulation)
    Oocite quality: Visit 5 (oocyte collection) and V6 (embryo transfer)
    Embryo quality: Visit 6 (embryo transfer)
    Final result: visit 7 (pregnancy test) and Visit 8 (pregnancy confirmation and TVUS)
    Ovariële stimulatie:
    Kwaliteit van oöcyten:
    Kwaliteit van het embryo:
    Eindresultaat:

    Stimulation ovarienne:
    Qualité des ovocytes:
    Qualité des embryons:
    Résultat final:
    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) 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 No
    E.8.1.3Single blind Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Italy
    Spain
    Switzerland
    Turkey
    United Kingdom
    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
    LVLS
    laatste bezoek laatste patiënt
    dernière visite dernier patient
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 720
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 720
    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)
    Patients with no pregnancy at the end of the trial can undergo a embryo transfer cycle within 1 year after their date of randomization.
    All patients with a pregnancy in the fresh cycle or in the 1-year post randomisation frozen-embryo transfer will be followed until delivery and live birth data will be collected.
    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 Decision2013-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-12
    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-Tue Apr 23 19:33:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA