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    Summary
    EudraCT Number:2012-004969-40
    Sponsor's Protocol Code Number:RHFERAMH-0001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-004969-40
    A.3Full title of the trial
    An AMH based indivdualised controlled ovarian stimulation regiment using
    Corifollitrophin or graded doses of rFSH versus a standard protocol. A
    randomised controlled trial
    Anti Mullersk Hormon (AMH) baseret stimulationsprotokol med
    corifollitrophin alfa og rekombinant FSH til in vitro fertilisering.
    Et randomiseret klinisk studium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An AMH based indivdualised controlled ovarian stimulation regiment using
    Corifollitrophin Alphs or graded doses of rFSH versus a standard protocol.
    A randomised controlled trial
    Individuel baseretstimulation af æggestokkene baseret på bedømmelse af kvindens ægreserve
    A.4.1Sponsor's protocol code numberRHFERAMH-0001
    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 SponsorFertility Clinic, Copenhagen University Hospital, Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportFertility Clinic, Copenhagen University Hospital, Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFertility Clinic, Copenhagen University Hospital, Rigshospitalet
    B.5.2Functional name of contact pointProfessor Anders Nyboe Andersen
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDK-2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535451315
    B.5.5Fax number+4535454946
    B.5.6E-mailanders.nyboe.andersen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    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 Puregon
    D.2.1.1.2Name of the Marketing Authorisation holderN.V Organon, Kloosterstraat 6, NL-5349 AB OSS, Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePuregon
    D.3.2Product code EU/1/96/008/018
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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.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 Elonva
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon, Kloosterstraat 6, NL-5349 AB OSS, Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameElonva
    D.3.2Product code EU/1/09/609/001
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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) Yes
    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
    In vitro fertilization include controlled ovarian stimulation (COS), where
    follicles are stimulated to full maturity.
    One of the main problems of the IVF treatment is still to some patients
    develop a very large number of follicles, and others only a few. A large
    number of follicles (eggs) increases the risk of ovarian hyperstimulation
    syndrome (OHSS), while few follicles (eggs) reduces the chance of
    pregnancy.
    E.1.1.1Medical condition in easily understood language
    The main problems of IVF treatment is different development of either a
    large number of follicles or only a few.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021930
    E.1.2Term Infertility NOS
    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 show that the group randomized to individual AMH based stimulation
    achieves a more homogeneous distribution of the retrieved eggs than
    the group receiving standard treatment.
    Primary endpoint:
    The primary endpoint is an appropriate or an inappropriate number of
    oocytes:
    This should be understood in the term of patients in the two arms are
    classified as having an appropriate response (5 - 14 eggs) or
    inappropriate response (<5 or> 14 eggs);
    An inappropriate response includes those patients where the treatment
    is canceled due to either too few follicles or egg maturation with hCG
    omitted due to risk of OHSS (given as GnRH agonist (Suprefact) instead
    of)
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic sub-study:
    The study will also include a "genetic part" of series of analyzes of both
    FSH, AMH and AMH receptor polymorphisms. Among the secondary end -
    points we will analyze whether there is a correlation between the
    detection of specific single nucleotide polymorphisms and patients'
    responses. We have recently shown that two genetic variants of AMH
    (Ile49Ser; rs10407022) and its specific type II receptor (AMHR2 -482
    A> G, rs2002555) genes are associated with estradiol levels in normally
    XML File Identifier: ZQ/kwrtTXRo4hlhIJ9zKTQfYxWQ=
    Page 15/26
    ovulating women, suggesting that these gene variants affect FSH
    sensitivity of the follicles.
    We will further analyze whether there is a correlation between the basal
    AMH and proven AMH receptor polymorphisms. It could, for example
    conceivable that there was a link between suboptimal functioning AMH
    receptor and the basal AMH, so that a dysfunctional AMH system leads to
    accelerated loss of ægreserve.
    Biostatistics part-study:
    This part will be using biostatistical modeling to analyze recruitment and
    maturation of antral follicles in order: What factors are the primary
    determinants of the percentage of registered antral follicles are
    recruited and mature. Follicular growth and endocrine responses will be
    carefully and frequently monitored.
    E.3Principal inclusion criteria
    - Women with evidence of COS a view IVFeller ICSI
    - First treatment with IVF / ICSI in the department
    - Age between 25-38 years;
    - AMH is between 5-50
    - Weight <75kg
    - Normal menstrual cycle length of 24 to 35 days, which are presumably
    ovulatory;
    - Two ovaries;
    - Uterus with expected normal function (eg. No clinically significant
    fribromer) documented by ultrasound at screening;
    - Willing and able to sign the informed consent.
    E.4Principal exclusion criteria
    -History of current PCOS or endometriosis stage III / IV
    -History of severe ovarian hyperstimulation syndrome;
    - Presence of hydrosalpinx by ultrasound;
    - History of recurrent consecutive miscarriages (> 3)
    -FSH> 12 IU / L (in the early follicular phase);
    - Contraindications for use of gonadotropins or GnRH analogues;
    -History of current epilepsy, HIV infection, diabetes or cardiovascular,
    gastrointestinal, hepatic, renal, or pulmonary disease;
    - Pregnancy, lactation or contraindication to pregnancy;
    - Current or previous (last 12 months) abuse of alcohol or drugs;
    - History of chemotherapy (except gestationelle reasons) and
    radiotherapy;
    - Undiagnosed vaginal bleeding;
    - Tumors of the ovary, breast, adrenal, pituitary or hypothalamus and
    malformations of sexual organs incompatible with pregnancy;
    - Abnormal karyotype of the patient (if karyotype is performed);
    - Hypersensitivity to study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    The primary endpoint is an appropriate or an inappropriate number of
    oocytes:
    This should be understood so that the patients in the two arms are
    classified as having an appropriate response (5 - 14 eggs) or
    inappropriate response (<5 or> 14 eggs);
    An inappropriate response includes those patients where the treatment
    is canceled due to either too few follicles or egg maturation with hCG
    omitted due to risk of OHSS (given as GnRH agonist (Suprefact) instead
    of)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of endpoint for the primary endpoint is Marts 2016
    E.5.2Secondary end point(s)
    -fertilization rate
    -Number transferede embryos
    - Number of patients who achieve blastocyst transfer ring
    - implantation rate
    - Duration of stimulation
    - Luteal phase inconvenience and enlargemen of ovaries
    - Clinical pregnancy (GA weeks 7-8)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timpoint will be Dec 2016 due to pregnancy at last patient
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 Yes
    E.8.2.3.1Comparator description
    Puregon 150 IU
    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 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
    "End of study" is when a pregnancy is categorized as ongoing ie.
    continue beyond 7 weeks at the last patient
    Within 90 days after the "End Study", the regional research ethics
    committee and the Danish Medicines Agency will be informed that the
    investigation is complete.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 216
    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 Yes
    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 state216
    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. Normal infertility treatment if not pregnant in paticipation in this
    trial
    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 Decision2012-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-10
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