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    Summary
    EudraCT Number:2018-004192-12
    Sponsor's Protocol Code Number:NL66079.029.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004192-12
    A.3Full title of the trial
    Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oil- based versus water-based contrast media for hysterosalpingography (HSG) in women with an unfulfilled childwish with ovulation disorders, at high risk for tubal pathology or above 38 years of age.
    A.3.2Name or abbreviated title of the trial where available
    H2Oil 2 study
    A.4.1Sponsor's protocol code numberNL66079.029.18
    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 SponsorAmsterdam UMC, location VU medical Center
    B.1.3.4CountryNetherlands
    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 supportAmsterdam UMC - location Vrije Universiteit Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, location VU medical Center
    B.5.2Functional name of contact pointdr. V. Mijatovic
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1118
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailmijatovic@vumc.nl
    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 Lipiodol UltraFluid
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameLipiodol Ultrafluid
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    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.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 Visipaque
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVisipaque
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The research population consists of infertile couples who have tried to conceive for at least 12 months, or have oligo- or anovulation. We will focus on women with ovulation disorders, or at high risk for tubal pathology or above 38 years of age.
    E.1.1.1Medical condition in easily understood language
    The research population consists of infertile couples who have tried to conceive for at least 12 months or have an irregular menstrual cycle or at high risk for tubal pathology or >38 years of age.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the proposed study is to assess the effectiveness and cost-effectiveness of the use of oil versus water-based contrast medium in terms of conception leading to live birth in women undergoing HSG, who:
    1: have ovulation disorders or;
    2: are at high risk for tubal pathology or;
    3: are above 38 years of age.
    E.2.2Secondary objectives of the trial
    Treatment outcome parameters:
    - Biochemical pregnancy
    - Clinical pregnancy
    - Ongoing pregnancy
    - Miscarriage
    - Ectopic pregnancy
    - Multiple pregnancy
    - Time to pregnancy
    - Complications following HSG (infection, intravastion)
    - Pregnancy outcomes (f.e. birth weight)
    - Pregnancy complications
    - Stillbirth
    - Thyroid function of the woman (before and 1 month after HSG)
    - Neonatal outcomes
    - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
    - Costs within 6 months after randomization
    - Thyroid function of neonate (determined by heelprick)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a women must meet one of the following criteria:
    1: with ovulation disorders (ovulation disorders will be defined as less than 8 menstrual cycles per year) or;
    2: at high risk for tubal pathology (high risk for tubal pathology will be defined as a positive chlamydia infection, a pelvic inflammatory disease, known endometriosis, abdominal surgery (including tubectomy for ectopic pregnancy and appendectomy) and/or peritonitis in the medical history) or;
    3: above 38 years of age
    E.4Principal exclusion criteria
    - Iodine allergy
    - Male subfertility defined as a post-wash total motile sperm count < 1 x10^6 spermatozoa/ml
    - Not willing or able to sign the consent form
    - Endocrine disorders as diabetes, hyperthyroidism or hyperprolactinemia (except for well managed hypothyroidism with TSH between 0.3 and 2.5mIU/l)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after randomization, unless a patiente is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy.
    E.5.2Secondary end point(s)
    Treatment outcome parameters:
    - Biochemical pregnancy
    - Clinical pregnancy
    - Ongoing pregnancy
    - Miscarriage
    - Ectopic pregnancy
    - Multiple pregnancy
    - Time to pregnancy
    - Complications following HSG (infection, intravastion)
    - Pregnancy outcomes (f.e. birth weight)
    - Pregnancy complications
    - Stillbirth
    - Thyroid function of the woman (before and 1 month after HSG)
    - Neonatal outcomes
    - Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
    - Costs within 6 months after randomization
    - Thyroid function of neonate (determined by heelprick)
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0: Time of randomization
    T1: Six months after randomization, unless a patient is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Cost-effectiveness
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    An HSG with a water-based contrast depending on local protocol.
    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 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 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
    6 months after randomization, unless a patiente is pregnant within the 6 months follow-up, then she will be followed until the end of the pregnancy.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 930
    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 state930
    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 Decision2019-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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