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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2017-002783-40
    Sponsor's Protocol Code Number:000304
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002783-40
    A.3Full title of the trial
    A randomised, controlled, open label, parallel group, multicentre trial
    comparing the efficacy and safety of individualised FE 999049 (follitropin
    delta) dosing, using a long GnRH agonist protocol and a GnRH antagonist
    protocol in women undergoing controlled ovarian stimulation
    Sperimentazione multicentrica, randomizzata, controllata, in aperto, a
    gruppi paralleli, volta a confrontare l'efficacia e la sicurezza del dosaggio
    personalizzato di FE 999049 (follitropina delta), usando un protocollo con
    agonista del GnRH ed un protocollo con antagonista del GnRH in donne
    sottoposte a stimolazione ovarica controllata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare the efficacy and safety of individualised FE 999049
    (follitropin delta) dosing in women undergoing controlled ovarian
    stimulation
    Sperimentazione volta a confrontare l'efficacia e la sicurezza del dosaggio
    personalizzato di FE 999049 (follitropina delta), in donne sottoposte a
    stimolazione ovarica controllata
    A.3.2Name or abbreviated title of the trial where available
    BEYOND
    BEYOND
    A.4.1Sponsor's protocol code number000304
    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 SponsorFerring Pharmaceutical A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointGlobal Clinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number004588338880
    B.5.6E-mailDK0-Disclosure@ferring.com
    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 REKOVELLE
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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 nameFE 999049
    D.3.2Product code [FE 999049]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 146479-72-3
    D.3.9.2Current sponsor codeFE 999049
    D.3.9.4EV Substance CodeSUB121093
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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 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
    Infertility in women undergoing assisted reproductive technologies
    (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm
    injection (ICSI) cycle
    Infertilità in donne che si sono sottoposte a tecniche di fecondazione assistita (ART) come la fertilizzazione in vitro (IVF) o iniezioni intracitoplasmatiche dispermatozoi (ICSI) a cicli.
    E.1.1.1Medical condition in easily understood language
    Infertility - Inability to conceive children
    Infertilità - Impossibilità di concepire bambini
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014787
    E.1.2Term Endometriosis of uterus
    E.1.2System Organ Class 100000004872
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10016403
    E.1.2Term Female infertility of tubal origin
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025511
    E.1.2Term Male infertility, unspecified
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014784
    E.1.2Term Endometriosis of ovary
    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
    To evaluate the effect of individualised FE 999049 treatment on ovarian
    response in a long GnRH agonist protocol versus a GnRH antagonist
    protocol
    Valutare l’effetto del trattamento personalizzato con FE 999049 sulla risposta ovarica in un protocollo lungo con agonista del GnRH rispetto a un protocollo con antagonista del GnRH
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of individualised FE 999049 treatment on other
    pharmacodynamic parameters in a long GnRH agonist protocol versus a
    GnRH antagonist protocol
    • To evaluate the effect of individualised FE 999049 treatment on
    pregnancy rates in a long GnRH agonist protocol versus a GnRH
    antagonist protocol
    • To evaluate the safety of individualised FE 999049 treatment in a long
    GnRH agonist protocol versus a GnRH antagonist protocol
    - Valutare l’effetto del trattamento personalizzato con FE 999049 su altri parametri farmacodinamici in un protocollo lungo con agonista del GnRH rispetto a un protocollo con antagonista del GnRH
    - Valutare l’effetto del trattamento personalizzato con FE 999049 sui tassi di gravidanza in un protocollo lungo con agonista del GnRH rispetto a un protocollo con antagonista del GnRH
    - Valutare la sicurezza del trattamento personalizzato con FE 999049 in un protocollo lungo con agonista del GnRH rispetto a un protocollo con antagonista del GnRH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent Documents signed prior to screening evaluations.
    2. In good physical and mental health.
    3. The subjects must be at least 18 years (including the 18th birthday)
    when they sign the informed consent and no more than 40 years (up to
    the day before the 41st birthday) at the time of randomisation.
    4. Infertile women diagnosed with tubal infertility, unexplained
    infertility, endometriosis stage I/II or with partners diagnosed with
    male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated
    sperm from male partner or sperm donor.
    5. Infertility for at least one year before randomisation for subjects <
    38 years or for at least 6 months for subjects =38 years (not applicable
    in case of tubal or severe male factor infertility).
    6. The trial cycle will be the subject's first controlled ovarian
    stimulation cycle for IVF/ICSI.
    7. Regular menstrual cycles of 24-35 days (both inclusive), presumed
    to be ovulatory.
    8. Hysterosalpingography, hysteroscopy, saline infusion sonography, or
    transvaginal ultrasound documenting a uterus consistent with expected
    normal function (e.g. no evidence of clinically interfering uterine fibroids
    defined as submucous or intramural fibroids larger than 3 cm in
    diameter, no polyps and no congenital structural abnormalities which are
    associated with a reduced chance of pregnancy) within 1 year prior to
    randomisation.
    9. Transvaginal ultrasound documenting presence and adequate
    visualisation of both ovaries, without evidence of significant abnormality
    (e.g. no endometrioma greater than 2 cm or enlarged ovaries which
    would contraindicate the use of gonadotropins) and normal adnexa (e.g.
    no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must
    be accessible for oocyte retrieval.
    10. Early follicular phase (cycle day 2-5) serum levels of FSH between 1
    and 15 IU/L at screening.
    11. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C
    Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests
    within 1 year prior to randomisation.
    12. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both
    inclusive) at screening.
    13. If < 38 years willing to accept single blastocyst transfer. If =38
    years willing to accept transfer of a single good-quality blastocyst
    (double blastocyst transfer may be performed if no good-quality
    blastocyst is available).
    1. Moduli di consenso informato firmati prima delle valutazioni di screening.
    2. In buona salute fisica e mentale.
    3. I soggetti devono avere almeno 18 anni (compreso il 18o compleanno) quando firmano il modulo di consenso informato e non più di 40 anni (fino al giorno prima del 41o compleanno) al momento della randomizzazione.
    4. Donne sterili che hanno avuto una diagnosi di infertilità tubarica, infertilità non spiegabile, endometriosi di I/II grado o con partner con diagnosi di infertilità maschile, considerate idonee per IVF (fertilizzazione in vitro) e/o ICSI (iniezione intracitoplasmatica dello spermatozoo) utilizzando sperma fresco o congelato di partner maschio o di donatore di sperma.
    5. Infertilità da almeno un anno prima della randomizzazione per soggetti di età <38 anni o da almeno 6 mesi per soggetti di età =38 anni (non applicabile in caso di infertilità tubarica o grave infertilità maschile).
    6. Il ciclo della sperimentazione sarà il primo ciclo di stimolazione ovarica controllata per IVF/ICSI del soggetto.
    7. Cicli mestruali regolari di 24-35 giorni (entrambi comprensivi), ritenuti ovulatori.
    8. Isterosalpingografia, isteroscopia, sonografia con soluzione fisiologica o ecografia transvaginale che documentino un utero consistente con la normale funzione richiesta (ad es., nessuna evidenza di fibromi uterini che interferiscono clinicamente definiti come fibromi intramurali o sottomucosali maggiori di 3 cm in diametro, nessun polipo e nessuna anomalia strutturale congenita associata con una minore possibilità di gravidanza) entro 1 anno prima della randomizzazione.
    9. Ecografia transvaginale che documenta la presenza e l’adeguata visualizzazione di entrambe le ovaie, senza evidenza di anomalie significative (ad es., nessun endometrioma maggiore di 2 cm oppure ovaie ingrossate che possano controindicare l’uso di gonadotropine) e annessi normali (ad es., nessuna idrosalpinge), entro 1 anno prima della randomizzazione. Entrambe le ovaie devono essere accessibili per il prelievo di ovociti.
    10. Livelli sierici di FSH nella fase follicolare precoce (giorni del ciclo 2-5) tra 1 e 15 UI/l allo screening.
    11. Test anticorpali sierici negativi per antigene di superficie del virus dell’epatite B (HBsAg), virus dell’epatite C (HCV) e virus dell’immunodeficienza umana (HIV) nell’anno che precede la randomizzazione.
    12. Indice di massa corporea (BMI) tra 17,5 e 32,0 kg/m2 (entrambi comprensivi) allo screening.
    13. I soggetti di età <38 anni devono essere disponibili ad accettare il trasferimento di una singola blastocisti. I soggetti di età =38 anni devono essere disponibili ad accettare il trasferimento di una singola blastocisti di buona qualità (il trasferimento di una doppia blastocisti può essere eseguito se non è disponibile alcuna blastocisti di buona qualità).
    E.4Principal exclusion criteria
    1. AMH >35 pmol/L at screening.
    2. Strong preference of the subject for either treatment protocol.
    3. Known endometriosis stage III-IV (defined by the revised American
    Society for Reproductive Medicine [ASRM] classification, 1996).
    4. Known history of recurrent miscarriage (defined as three consecutive
    losses after ultrasound confirmation of pregnancy (excl. ectopic
    pregnancy) and before week 24 of pregnancy).
    5. Known abnormal karyotype of subject or of her partner / sperm
    donor, as applicable, depending on source of sperm used for
    insemination in this trial.
    6. Any known clinically significant systemic disease (e.g. insulin-
    dependent diabetes).
    7. Known inherited or acquired thrombophilia disease.
    8. Active arterial or venous thromboembolism or severe
    thrombophlebitis, or a history of these events.
    9. Known porphyria.
    10. Any known endocrine or metabolic abnormalities (pituitary,
    adrenal, pancreas, liver or kidney) with the exception of controlled
    thyroid function disease.
    11. Known tumours of the ovary, breast, uterus, adrenal gland,
    pituitary or hypothalamus which would contraindicate the use of
    gonadotropins.
    12. Known moderate or severe impairment of renal or hepatic function.
    13. Currently breast-feeding.
    14. Undiagnosed vaginal bleeding.
    15. Known abnormal cervical cytology of clinical significance observed
    within 3 years prior to randomisation (unless the clinical significance has
    been resolved).
    16. Findings at the gynaecological examination at screening which
    preclude gonadotropin stimulation or are associated with a reduced
    chance of pregnancy, e.g. congenital uterine abnormalities or retained
    intrauterine device.
    17. Pregnancy (negative pregnancy test must be documented at
    screening) or contraindication to pregnancy.
    18. Known current active pelvic inflammatory disease.
    19. Use of fertility modifiers during the last menstrual cycle before
    randomisation, including dehydroepiandrosterone (DHEA), metformin or
    cycle programming with oral contraceptives, progestogen or estrogen
    preparations.
    20. Use of hormonal preparations (except for thyroid medication)
    during the last menstrual cycle before randomisation.
    21. Known history of chemotherapy (except for gestational conditions)
    or radiotherapy.
    22. Current or past (1 year prior to randomisation) abuse of alcohol or
    drugs and/or current (last month) intake of more than 14 units of
    alcohol per week.
    23. Current or past (3 months prior to randomisation) smoking habit of
    more than 10 cigarettes per day.
    24. Hypersensitivity to any active ingredient or excipients in the
    medicinal products used in the trial.
    25. Previous participation in the trial
    26. Use of any non-registered investigational drugs during the last 3
    months prior to randomisation.
    See also Withdrawal Criteria in the study protocol.
    1. AMH >35 pmol/l allo screening.
    2. Spiccata preferenza del soggetto per uno dei due protocolli di trattamento.
    3. Nota endometriosi allo stadio III-IV (definita in base alla classificazione rivista della American Society for Reproductive Medicine [ASRM], 1996).
    4. Nota anamnesi di aborto ricorrente (definito come tre perdite consecutive dopo conferma ecografica di gravidanza [ad esclusione di gravidanza ectopica] e prima della settimana 24 di gravidanza).
    5. Noto cariotipo anormale del soggetto o del suo partner/donatore di sperma, come pertinente, a seconda della fonte di sperma utilizzato per l’inseminazione in questa sperimentazione.
    6. Qualsiasi malattia sistemica clinicamente significativa nota (ad es., diabete legato all’insulina).
    7. Malattia di trombofilia acquisita o ereditata nota.
    8. Tromboembolismo venoso o arterioso attivo oppure tromboflebite grave oppure un’anamnesi di questi eventi.
    9. Porfiria nota.
    10. Qualsiasi anomalia endocrina o metabolica nota (pituitaria, surrenale, pancreas, fegato o reni), ad eccezione di malattia della funzione tiroidea sotto controllo.
    11. Tumori di ovaie, seno, utero, ghiandola surrenale, pituitaria o ipotalamo che possano controindicare l’uso di gonadotropine.
    12. Insufficienza renale o epatica moderata o grave nota.
    13. Allattamento al seno in corso.
    14. Sanguinamento vaginale non diagnosticato.
    15. Nota citologia cervicale anormale clinicamente rilevante osservata nei 3 anni che precedono la randomizzazione (a meno che la significatività clinica non sia stata risolta).
    16. Risultati della visita ginecologica allo screening che precludono la stimolazione gonadotropinica o associati a ridotte possibilità di gravidanza, ad es., anomalie uterine congenite oppure mantenuto dispositivo intrauterino.
    17. Gravidanza (il test di gravidanza negativo deve essere documentato allo screening) oppure controindicazione riguardo alla gravidanza.
    18. Nota malattia infiammatoria pelvica attiva in corso.
    19. Uso di modificatori della fertilità durante l’ultimo ciclo mestruale prima della randomizzazione, ivi compresi deidroepiandrosterone (DHEA), metformina oppure programmazione del ciclo con contraccettivi orali, preparati contenenti progestinici o estrogeni.
    20. Uso di preparati ormonali (ad eccezione di farmaci per la tiroide) durante l’ultimo ciclo mestruale prima della randomizzazione.
    21. Nota anamnesi di chemioterapia (ad eccezione di condizioni gestazionali) o radioterapia.
    22. Abuso di alcolici e sostanze stupefacenti corrente o passato (1 anno prima della randomizzazione) e/o assunzione attuale (ultimo mese) di più di 14 unità di alcol alla settimana.
    23. Vizio del fumo corrente o passato (3 mesi prima della randomizzazione) di oltre 10 sigarette al giorno.
    24. Ipersensibilità verso qualsiasi ingrediente attivo o eccipiente contenuto nei prodotti medicinali utilizzati nella sperimentazione.
    25. Precedente partecipazione a questa sperimentazione clinica.
    26. Uso di qualsiasi farmaco sperimentale non registrato entro gli ultimi 3 mesi prima della randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    Number of oocytes retrieved
    Numero di ovociti estratti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation
    Il prelievo degli ovociti avverrà nelle 36 ore (±2 ore) successive all’attivazione della maturazione follicolare finale
    E.5.2Secondary end point(s)
    • Proportion of subjects with cycle cancellation due to poor ovarian
    response or excessive ovarian response
    • Proportion of subjects with blastocyst transfer cancellation after
    oocyte retrieval due to (risk of) ovarian hyperstimulation syndrome
    (OHSS)
    • Number and size of follicles on stimulation day 6 and end-of-
    stimulation
    • Proportion of subjects with <4, 4-7, 8-14, 15-19 and =20 oocytes
    retrieved
    • Number of metaphase II oocytes (only applicable for those
    inseminated using ICSI), fertilisation rate as well as number and quality
    of embryos on day 3 and blastocysts on day 5 after oocyte retrieval
    • Circulating concentrations of FSH, luteinising hormone (LH),
    estradiol, progesterone and inhibin B on stimulation day 6, end-of-
    stimulation and at oocyte retrieval
    • Total gonadotropin dose and number of stimulation days
    • Positive ßhCG rate (positive serum ßhCG test 13-15 days after
    transfer)
    • Implantation rate (number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred)
    • Clinical pregnancy rate (at least one gestational sac 5-6 weeks after
    transfer)
    • Vital pregnancy rate (at least one intrauterine gestational sac with
    fetal heart beat 5-6 weeks after transfer)
    • Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11
    weeks after transfer
    • Ongoing implantation rate (number of intrauterine viable fetuses 10-
    11 weeks after transfer divided by number of blastocysts transferred)
    • Proportion of subjects with early OHSS (including OHSS of
    moderate/severe grade)
    • Proportion of subjects with late OHSS (including OHSS of
    moderate/severe grade)
    • Frequency and intensity of adverse events
    • Technical malfunctions of the prefilled injection pen
    - Percentuale di soggetti con cancellazione del ciclo a causa di scarsa risposta ovarica oppure risposta ovarica eccessiva
    - Percentuale di soggetti con cancellazione del trasferimento di blastocisti dopo estrazione degli ovociti a causa di (rischio di) sindrome da iperstimolazione ovarica (OHSS)
    - Numero e dimensione dei follicoli al giorno 6 di stimolazione e alla conclusione della stimolazione
    - Percentuale di soggetti con <4, 4-7, 8-14, 15-19 e =20 ovociti estratti
    - Numero di ovociti in metafase II (applicabile solo alle donne inseminate mediante ICSI), tasso di fecondazione nonché numero e qualità degli embrioni al giorno 3 e blastocisti al giorno 5 dopo il prelievo di ovociti
    - Concentrazioni circolanti di FSH, ormone luteinizzante (LH), estradiolo, progesterone e inibina B al giorno 6 della stimolazione, al completamento della stimolazione e al prelievo di ovociti
    - Dose di gonadotropina totale e numero di giorni di stimolazione
    - Tasso positivo di ßhCG (dosaggio di ßhCG sierico positivo 13-15 giorni dopo il trasferimento)
    - Tasso di impianto (numero di sacche gestazionali 5-6 settimane dopo il trasferimento diviso per il numero di blastocisti trasferite)
    - Tasso di gravidanza clinica (almeno una sacca gestazionale 5-6 settimane dopo il trasferimento)
    - Tasso di gravidanza vitale (almeno una sacca gestazionale intrauterina con battito cardiaco fetale 5-6 settimane dopo il trasferimento)
    - Tasso di gravidanza in corso (almeno un feto vitale intrauterino 10-11 settimane dopo il trasferimento)
    - Tasso di impianto in corso (numero di feti vitali intrauterini 10-11 settimane dopo il trasferimento diviso per il numero di blastocisti trasferite)
    - Percentuale di soggetti con OHSS (ivi compresa OHSS di grado moderato/grave) precoce
    - Percentuale di soggetti con OHSS (ivi compresa OHSS di grado moderato/grave) tardiva
    - Frequenza e intensità degli eventi avversi
    - Malfunzionamenti tecnici della penna per iniezione preriempita
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint is included in the relevant endpoint
    Il tempo di rilevazione è incluso in ciacsun end-point
    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
    stesso prodotto in un protocollo lungo con agonista del GnRH o un protocollo con antagonista del GnR
    same product in long GnRH agonist arm or GnRH antagonist arm
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Austria
    Denmark
    Italy
    Netherlands
    Norway
    Switzerland
    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
    End of trial is Post-trial follow-up period completed Q3 2021
    La conclusione della sperimentazione avverrà al completamento del periodo di follow-up post-studio nel terzo trimestre del 2021
    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 months7
    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 months7
    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: 400
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 400
    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)
    Post-trial activities cover pregnancy and neonatal health follow-up. All
    subjects with an ongoing pregnancy will be followed till delivery to
    gather information on live birth rate. Furthermore, data will be
    gathered on neonatal health, including minor/major congenital
    anomalies, at birth and at 4 weeks after birth. These data will be
    reported separately.
    Le attività post-sperimentazione coprono la gravidanza e il follow-up della salute neonatale. Tutti i soggetti con una gravidanza in corso saranno seguiti fino al parto per raccogliere informazioni riguardo al tasso di nascite vive. Inoltre, saranno raccolti dati riguardanti la salute neonatale, ivi comprese anomalie congenite minori/maggiori, alla nascita e a 4 settimane dopo la nascita. Questi dati saranno comunicati separatamente.
    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 Decision2019-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Sun May 05 22:28:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA