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    Summary
    EudraCT Number:2015-005682-24
    Sponsor's Protocol Code Number:RIOTA2015
    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:2016-01-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2015-005682-24
    A.3Full title of the trial
    REDUCING THE IMPACT OF OVARIAN STIMULATION - THE RIOT PROJECT
    STUDY RIOT A: THE ROLE OF AROMATASE INHIBITOR IN REDUCING THE DETRIMENTAL EFFECTS OF OVARIAN STIMULATION TO OPTIMIZE OUTCOMES IN FRESH EMBRYO TRANSFER CYCLES
    RIOT STUDIE A: INTERVENTION MED AROMATASEHÆMMER FOR AT OPNÅ OPTIMERET RESPONS AF FOLLIKELSTIMULATIONEN VED FRISK IN VITRO FERTILITATIONS (IVF) BEHANDLING
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RIOT STUDY A: IS THERE A BETTER CHANCE OF ACHIEVING PREGNANCY UNDER FERTILIZATION TREATMENT WHEN AN AROMATASE INHIBITOR IS ADDED TO THE TREATMENT?
    RIOT STUDIE A: ER DER BEDRE GRAVIDITETSCHANCE VED FERTILITETSBEHANDLING, NÅR ÆG-MODTAGELIGHEDEN I LIVMODERSLIMHINDEN OPTIMERES MED TILLÆGSBEHANDLING MED EN AROMATASEHÆMMER?
    A.3.2Name or abbreviated title of the trial where available
    RIOT-A
    A.4.1Sponsor's protocol code numberRIOTA2015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02946684
    A.5.4Other Identifiers
    Name:Regional Scientific Ethics CommitteeNumber:H - 15021850
    Name:Danish Data Protection AgencyNumber:HGH-2016-045;I-04513
    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 SponsorSven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev/Gentofte Hospital
    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 supportReproUnion
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev Hospital
    B.5.2Functional name of contact pointUnit of Reproductive Medicine
    B.5.3 Address:
    B.5.3.1Street AddressPavillionbygning 63 C7F, Herlev Ringvej 76
    B.5.3.2Town/ city Herlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538683796
    B.5.6E-mailsven.olaf.skouby@regionh.dk
    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 Letrozol "Accord"
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Research Limited Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, Storbritann
    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 nameLetrozol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 placeboCapsule
    D.8.4Route of administration of the placeboGastroenteral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility
    Infertilitet
    E.1.1.1Medical condition in easily understood language
    Infertility
    Barnløshed
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016401
    E.1.2Term Female infertility of other specified origin
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016403
    E.1.2Term Female infertility of tubal origin
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves luteal phase parameters during IVF.
    Projektets formål er at undersøge om østradiol hæmning opnået ved adjuverende behandling med aromatase inhibitor under IVF forbedrer parametrene af den luteale fase.
    E.2.2Secondary objectives of the trial
    Oocyte fertilisation, embryo quality, implantantation, pregnancy rate
    Oocyt fertilisation, embryo kvalitet, implantation, graviditetsrate
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    EudraCT number 2015-005683-41

    RIOT-B: Mapping the endocrine determinants of cycle wave secondarily recruited follicles

    Primary endpoints:
    1. Size of follicle cohort in relation to serum endocrine and paracrine markers including
    AMH, Estradiol, FSH, LH, Testosterone, Progesterone, 17-Hydroxyprogesterone
    PAPP-A and A2
    Inhibin A and B
    BMPs
    2. Size of the cyclically recruited follicle cohort (AFC) after ovarian stimulation with and without co-treatment with AI.
    3. Expression of cytokine and growth factors in endometrial secretions, uterine contractility and follicular fluid endocrine and paracrine markers following co-treatment with AI compared with placebo control.

    Secondary endpoints:
    Area under the curve from day 4 to day 10 post hCG administration for, P and 17-hydroxyprogesterone (17-HP).
    2. Serum E2, P and T levels on Stimulation day 5, day of hCG administration (or the day before), day of oocyte pick up, day 7 and 10 after hCG administration.
    3. Total IU of FSH used per cycle.
    4. Number of follicles > 12 mm on day of hCG (or the day before) and oocytes obtained.
    5. Proportion of oocytes resulting in top quality day 2 (or day 3) embryos according to validated morphological criteria.
    6. Oocyte fertilization rate
    7. Number and quality of embryos obtained.
    8. Endometrial thickness on day of hCG (or the day before) and day of embryo transfer.
    9. Uterine contraction rate (contractions/minute) day 3 or 4 or 5 after ovulation (determined by urine LH test) in natural cycle and just prior to embryo transfer in stimulated cycle
    10. Implantation rate, biochemical and ongoing pregnancy rate (viable intra-uterine pregnancy recorded at week 7-8 ultrasound).
    11. Reported side effects
    12. Morphometric/kinetic markers of embryo quality



    EudraCT number 2015-005683-41

    RIOT-B: Kortlæggelse af de endokrine determinanter for cyklisk sekundært rekrutterede follikler
    E.3Principal inclusion criteria
    Indication for IVF/ICSI treatment
    Eligible for IVF/ICSI treatment according to local criteria
    IVF/ICSI treatment with single embryo transfer
    Regular cycles 21-35 days (both included)
    Age < 40
    AMH 8- 32 (both included)
    Written consent
    E.4Principal exclusion criteria
    Any contraindication for IVF/ICSI treatment according to local criteria
    Previous stimulation for IVF/ICSI with < 4 oocytes obtained
    PCOS
    Undergoing IVF/ICSI for the purpose of fertility preservation
    Allergy towards study drug

    After inclusion the participants will be excluded from further participation in the trial in case of
     Withdrawal of consent
     Lack of compliance with study medication
     Medical complications arising from IVF treatment that would require the cycle to be terminated on clinical grounds
     Serious adverse event or reaction including severe allergy to study drug or developing an excessive response to ovarian hyperstimulation in the follicular phase for which termination of all medication was required.
     Specific adverse reactions to study drug: severe degree of hot flushes, severe degree of nausea/vomiting, severe degree of muscle and joint pain.

    Participants who are withdrawn from the study will be replaced by inclusion of new participants.
    Should the study participant present with ovarian cyst or inadequate endometrium thickness according to local guidelines on the initial ultrasound scan, the participant will be managed according to local clinical policies. The participant can be randomized when she is considered ready to commence ovarian stimulation according to local protocols.
    In case of a low response to stimulation resulting in cancellation of the cycle before oocyte retrieval, or when no embryos are available for transfer, the participant will be withdrawn from further participation. Both instances will be addressed in the report of results.
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum progesterone level on day of hCG

    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient recruitment: November – August 2018
    Data analysis: March 2018 – March 2019
    Publication of results: December 2018 – March 2019
    Patient rekruttering: November 2016 – August 2018
    Data analyse: August 2018 – Marts 2019
    Publikation af resultater: December 2018 – Marts 2019
    E.5.2Secondary end point(s)
    1. Area under the curve from day 4 to day 10 post hCG administration for P and 17-hydroxyprogesterone (17-HP).

    2. Serum E2, androstenedione and testosterone (T) levels on Stimulation day 5, on the day of hCG administration (or the day before), day of oocyte pick up (OPU), day 7 after hCG administration and day 10 after hCG.

    3. Follicular fluid E2, androstenedione, T, inhibin B and AMH levels

    4. Total IU of FSH used per cycle.

    5. Number of follicles > 12 mm on day of hCG (or the day before) and oocytes obtained.

    6. Proportion of oocytes resulting in top quality day 2 (or day 3) embryos according to validated morphological criteria.

    7. Oocyte fertilization rate

    8. Number and quality of embryos obtained, including rate of blastocyst formation.

    9. Endometrial thickness on day of hCG (or the day before) and day of embryo transfer.

    10. Implantation rate, biochemical and ongoing pregnancy rate (viable intra-uterine pregnancy recorded at week 7-8 ultrasound).

    11. Reported side effects

    12. Morphometric/kinetic markers of embryo quality
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient recruitment: November 2016 – March 2018
    Data analysis: March 2018 – September 2018
    Publication of results: September 2018 – March 2019
    Patient rekruttering: November 2016 – Marts 2018
    Data analyse: Marts 2018 – September 2018
    Publikation af resultater: September 2018 – Marts 2019
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 128
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    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
    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 Decision2016-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-30
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