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    Summary
    EudraCT Number:2016-005208-24
    Sponsor's Protocol Code Number:hCG-GR-001-2016
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-05-05
    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 ConcernedGreece - EOF
    A.2EudraCT number2016-005208-24
    A.3Full title of the trial
    A prospective, multicenter, double-blind, randomized, placebo-controlled, two-parallel groups Phase IIIb clinical study, to assess the efficacy and safety of adding low doses of hCG at a short IVF protocol with GnRH agonist and controlled ovular stimulation with recombinant FSH (rFSH) at the beginning of the follicular phase and during the whole stimulation period in infertile women of older age who are undergoing IVF, on the number of embryos to be transferred
    Μια προοπτική, πολυκεντρική, τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο (placebo), δύο παράλληλων ομάδων ασθενών, φάσης ΙΙΙb κλινική μελέτη, για τον έλεγχο της αποτελεσματικότητας και της ασφάλειας της προσθήκης χαμηλών δόσεων hCG σε βραχύ πρωτόκολλο με GnRH αγωνιστή και ελεγχόμενη ωοθηκική διέγερση με ανασυνδυασμένη FSH (rFSH) από την αρχή της ωοθυλακικής φάσης και καθ’ όλη τη διάρκεια της διέγερσης σε υπογόνιμες γυναίκες αυξημένης ηλικίας οι οποίες υποβάλλονται σε εξωσωματική γονιμοποίηση (IVF) στην αύξηση του αριθμού των εμβρύων προς μεταφορά
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Addition of low doses of hCG in the rFSH stimulation of infertile women of older age who are undergoing IVF
    Προσθήκη χαμηλών δόσεων hCG στην διέγερση με ανασυνδυασμένη FSH σε υπογόνιμες γυναίκες αυξημένης ηλικίας που υποβάλλονται σε εξωσωματική γονιμοποίηση
    A.4.1Sponsor's protocol code numberhCG-GR-001-2016
    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 SponsorProf. Harry Siristatidis
    B.1.3.4CountryGreece
    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 supportProf. Harry Siristatidis
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCORONIS Research
    B.5.2Functional name of contact pointHarry Therianos
    B.5.3 Address:
    B.5.3.1Street Address2, Nikitara st., Chalandri
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code152 32
    B.5.3.4CountryGreece
    B.5.4Telephone number+302108778 000
    B.5.5Fax number+302108778 202
    B.5.6E-mailhtherianos@coronis.gr
    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 Pregnyl
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 namehuman Chorionic Gonadotropin, hCG
    D.3.2Product code SUB01277MIG
    D.3.4Pharmaceutical form Lyophilisate and solvent for 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.3.8INN - Proposed INNhuman Chorionic Gonadotropin
    D.3.9.1CAS number 9002-61-3
    D.3.9.3Other descriptive nameHUMAN CHORIONIC GONADOTROPIN
    D.3.9.4EV Substance CodeSUB01277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate and solvent for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility
    Υπογονιμότητα
    E.1.1.1Medical condition in easily understood language
    Infertility
    Υπογονιμότητα
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10021928
    E.1.2Term Infertility female
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to investigate whether the addition of low doses of hCG in a short protocol IVF with GnRH and controlled ovular stimulation with rFSH from the beginning of the follicular phase up to the whole stimulation period, on infertile women of older age (35-40 yrs) undergoing IVF may enhance the number of embryos to be transferred

    Primary endpoint: the number of embryos to be transferred
    Στόχος της μελέτης είναι να ερευνήσει αν η προσθήκη χαμηλών δόσεων hCG σε βραχύ πρωτόκολλο εξωσωματικής γονιμοποίησης με GnRH-αγωνιστή και ελεγχόμενη ωοθηκική διέγερση με rFSH από την αρχή της ωοθυλακικής φάσης και καθ’όλη τη διάρκεια της διέγερσης σε υπογόνιμες γυναίκες αυξημένης ηλικίας (35-40 ετών) που υποβάλλονται σε εξωσωματική γονιμοποίηση (IVF), βελτιώνει τον αριθμό των εμβρύων προς μεταφορά.

    Kύριο καταληκτικό σημείο: ο αριθμός των εμβρύων προς μεταφορά
    E.2.2Secondary objectives of the trial
    • The number of follicles (>11, >14, >18 mm) at the day of the follicles' triggering with hCG,
    • The endometrium thickness at the day of the follicles' triggering with hCG
    • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in ultrasound)
    • The percentage of birth of living newborns
    • The percentage of automatic abortions (loss of pregnancy following a positive embryo cardiac function, after 12 weeks of gestation)
    • The percentage of continuing pregnancies (positive embryo cardiac function, after 12 weeks of gestation)
    • The percentage of the Ovarian HyperStimulation Syndrome (OHSS), following hCG triggering, during the next two weeks)
    • The percentage of multiple gestation.
    • O αριθμός των ωοθυλακίων (>11, >14, >18 mm) κατά την ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Tο πάχος του ενδομητρίου κατά την ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Το ποσοστό των κλινικών κυήσεων (ύπαρξη θετικής καρδιακής λειτουργίας στις 7 εβδομάδες κύησης στο υπερηχογράφημα)
    Tα ποσοστά γέννησης ζώντων νεογνών
    • Tα ποσοστά αυτομάτων εκτρώσεων (απώλεια εγκυμοσύνης, μετά θετική καρδιακή λειτουργία έως τις 20 εβδομάδες κύησης)
    • Tο ποσοστό συνεχιζόμενης κύησης (θετική καρδιακή λειτουργία μετά τις 12 εβδομάδες κύησης
    • Tο ποσοστό συνδρόμου υπερδιέγερσης των ωοθηκών (μετά τη χορήγηση [triggering] hCG για τις επόμενες 2 εδβομάδες)
    • Tο ποσοστό πολύδυμης κύησης
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: between 35 and 40 years,
    2. Normal menstrual cycle (cycle duration: 24-35 days),
    3. Normal endocrine function (normal values of PRL and TSH, FSH ≤ 15 IU/ml),
    4. Transvaginal ultrasound without abnormal findings,
    5. Medical history devoid of any finding,
    6. Indication for IVF/ICSI (NICE, 2016)
    7. 1st or 2nd IVF/ICSI cycle
    1. Ηλικία: μεταξύ 35 και 40 ετών,
    2. Φυσιολογικοί εμμηνορρυσιακοί κύκλοι (κύκλος 24-35 ημερών),
    3. Φυσιολογική ενδοκρινική λειτουργία (φυσιολογικές τιμές PRL και TSH, FSH ≤ 15 IU/ml),
    4. Διακολπικό υπερηχογράφημα (TVS) χωρίς παθολογικά ευρήματα,
    5. Ελεύθερο ιατρικό ιστορικό,
    6. Ένδειξη για IVF/ICSI (NICE, 2016)
    7. 1ος ή 2ος κύκλος IVF/ICSI
    E.4Principal exclusion criteria
    1. Εndocrine or metabolic diseases, e.g. PCO (S)
    2. Presence of any uterine or endometrium pathology,
    3. Pelvic inflammatory disease (PID),
    4. Basic FSH levels > 15 IU / ml,
    5. Previous ovaries surgical intervention,
    6. BMI ≥ 35 kg/m2,
    7. Age: < 35 & > 40 years
    1. Ενδοκρινικές ή μεταβολικές διαταραχές, π.χ. PCO (S)
    2. Παθολογία της μήτρας ή/και του ενδομητρίου,
    3. Φλεγμονώδης νόσος της πυέλου (PID),
    4. Βασικά επίπεδα FSH> 15 IU / ml,
    5. Χειρουργική επέμβαση στις ωοθήκες,
    6. Δείκτης μάζας σώματος (BMI) ≥ 35 kg / m2,
    7. Ηλικία: < 35 ετών & > 40 ετών
    E.5 End points
    E.5.1Primary end point(s)
    The number of (produced) embryos to be transferred
    O αριθμός των (παραγόμενων) εμβρύων προς μεταφορα
    E.5.1.1Timepoint(s) of evaluation of this end point
    14-17 days following the initiation of the current IVF cycle
    14-17 ημέρες μετα την έναρξη του τρέχοντος κύκλου εξωσωματικής
    E.5.2Secondary end point(s)
    • The number of follicles (>11, >14, >18 mm) at the day of follicles' triggering with hCG
    • The endometrium thickness at the day of follicles' triggering with hCG
    • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in the ultrasound test)
    • The percentage of birth of living newborns
    • The percentage of automatic abortions (lost of pregnancy following a positive cardiac function at 20 weeks)
    • The percentage of continuing pregnancies (positive cardiac function after 12 weeks of gestation)
    • The percentage of the Ovarian HyperStimulation Syndrome (OHSS) (during the 2 weeks time following follicular triggering with hCG)
    • The percentage of multiple gestation.
    • O αριθμός των ωοθυλακίων (>11, >14, >18 mm) κατά την ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Tο πάχος του ενδομητρίου κατά την ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Το ποσοστό κλινικής κύησης (ύπαρξη θετικής καρδιακής λειτουργίας στις 7 εβδομάδες κύησης στο υπερηχογράφημα)
    • Tα ποσοστά γέννησης ζώντων νεογνών
    • Tα ποσοστά αυτομάτων εκτρώσεων (απώλεια εγκυμοσύνης, μετά θετική καρδιακή λειτουργία έως τις 20 εβδομάδες κύησης)
    • Tο ποσοστό συνεχιζόμενης κύησης (θετική καρδιακή λειτουργία μετά τις 12 εβδομάδες κύησης),
    • Tο ποσοστό συνδρόμου υπερδιέγερσης των ωοθηκών (μετά τη χορήγηση [triggering] hCG για τις επόμενες 2 εδβομάδες)
    • Tο ποσοστό πολύδυμης κύησης.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • At the day of follicles' triggering with hCG
    • At the day of follicles' triggering with hCG
    • At the 7th week of gestation
    • At 20 weeks of gestation
    • After 12 weeks of gestation)
    • The percentage of the Ovarian
    • 2 weeks following follicular triggering with hCG
    • Tην ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Tην ημέρα της ωρίμανσης των ωοθυλακίων (triggering) με hCG,
    • Στην 7η εβδομάδα της κύησης
    • Mετά θετική καρδιακή λειτουργία έως τις 20 εβδομάδες κύησης
    • Θετική καρδιακή λειτουργία μετά τις 12 εβδομάδες κύησης
    • Για τις επόμενες 2 εδβομάδες, μετά τη χορήγηση [triggering] hCG
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 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 Yes
    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
    Τελευταία επίσκεψη τελευταίας ασθενούς
    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
    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: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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
    Κανένα
    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 Decision2017-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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