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    Summary
    EudraCT Number:2020-002135-30
    Sponsor's Protocol Code Number:NCT04379973
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-002135-30
    A.3Full title of the trial
    Live birth after additional tubal flushing with oil-based contrast versus no additional flushing: a randomised, multicentre, parallel group pragmatic trial in infertile women with at least one patent tube at Hysterosalpingo-foam sonography
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study concerning the influence of tubal flushing with oil on pregnancy and live birth in women with fertility problems.
    A.3.2Name or abbreviated title of the trial where available
    HYFOIL
    A.4.1Sponsor's protocol code numberNCT04379973
    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 SponsorAntwerp University Hospital (UZA)
    B.1.3.4CountryBelgium
    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 supportBeglian Health Care Knowledge Center (KCE
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntwerp University Hospital (UZA)
    B.5.2Functional name of contact pointIris Verhaegen
    B.5.3 Address:
    B.5.3.1Street AddressDrie Eikenstraat 655
    B.5.3.2Town/ cityEdegem
    B.5.3.3Post code2650
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3238213544
    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® Ultra Fluide
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Solution for 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
    Infertility defined as lack of conception despite 12 months of unprotected intercourse, or three cycles of donor insemination without pregnancy or three ovulatory ovulation induction cycles without pregnancy
    E.1.1.1Medical condition in easily understood language
    Infertility
    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
    To determine if the additional tubal flushing with oil-based contrast after undergoing Hyfosy significantly improves the occurrence rate of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy compared to no additional flushing after undergoing Hyfosy.
    E.2.2Secondary objectives of the trial
    • To compare reproductive outcomes
    • To compare gestational age at delivery, pregnancy complications and neonatal outcomes like birth weight, neonatal mortality, major congenital anomaly and thyroid function of the child(ren) between the intervention and the control group for women achieving a pregnancy > 22 weeks
    • To compare maternal thyroid function between the intervention and the control group:
    • To compare number of complications during or immediately after the intervention between the intervention and the control group
    • To compare pain scores of the Hyfosy between the intervention and the control group and to compare pain scores between Hyfosy and flush in the intervention group
    • To compare the general quality of life (EQ-5D-5L) and disease-specific quality of life (FertiQol questionnaire) (20, 21) between the intervention and the control group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infertile women undergoing Hyfosy as part of the fertility workup.
    Women will be eligible if they
    • are ≥ 18 years and < 40 years
    • have infertility defined as
    o lack of conception despite 12 months of unprotected intercourse OR;
    o if they are taking part in a donor sperm insemination programme: three cycles of donor insemination without pregnancy OR;
    o in case of treated ovulation disorder: three ovulatory ovulation induction cycles without pregnancy
    • have tubal patency of at least one Fallopian tube on Hyfosy
    E.4Principal exclusion criteria
    Women with
    • known iodine allergy
    • ovulation disorders defined as less than eight menstrual cycles per year who did not have three ovulatory cycles after ovulation induction
    • contra-indication to have tubal patency testing according to the site’s indication
    • active thyroid disorders (other than treated subclinical hypothyroidism because these may be included)
    • untreated subclinical hypothyroidism (TSH>2.5IU/L)
    • uterine surgery in the past two months before Hyfosy
    • a male partner (if applicable) with a post-wash Total Motile Sperm Count (TMC) < 1x106 and/or TMC < 3x106 in the native sperm analysis [TMC is defined as volume X concentration X (A (progressive) + B (non progressive) motility in %) divided by 100]
    • an indication for IVF
    • no Belgian national number (RRN/INS)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence of live birth, counting from the first day of the last menstrual cycle in which the patient conceives within 6 months after Hyfosy.
    The endpoint is chosen to reflect efficacy (beneficial effect of the tubal flush with 5-10mL OSCM compared to Hyfosy without additional flushing).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-partum
    E.5.2Secondary end point(s)
    • Reproductive outcomes: clinical pregnancy, ongoing pregnancy, ectopic pregnancy, multiple pregnancy and miscarriage
    • For women achieving a pregnancy > 22 weeks:
    o Gestational age at delivery
    o Birth weight
    o Neonatal mortality
    o Major congenital anomaly
    o Neonatal outcomes and thyroid function of the child(ren)
    o Pregnancy complications
    • Maternal thyroid function: TSH, FT4 at 4 weeks, 26 weeks for all patients and at delivery or end of pregnancy when pregnant
    • Number of complications during or immediately after the intervention (embolism, anaphylactic shock, pelvic inflammatory disease)
    • Pain score of the Hyfosy (as measured by VAS)
    • Pain score of the additional flush (as measured by VAS) in the intervention group
    • General (EQ-5D-5L) and disease-specific quality of life (FertiQol questionnaire)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Reproductive outcomes: during pregnancy
    • For women achieving a pregnancy > 22 weeks: Post-partum
    • Maternal thyroid function: at 4 weeks, 26 weeks for all patients and at delivery or end of pregnancy when pregnant
    • Number of complications during or immediately after the intervention
    • Pain scores: immediately after Hyfosy and intervention
    • General (EQ-5D-5L) and disease-specific quality of life (FertiQol questionnaire): 26 weeks
    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) 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
    No intervention with IMP
    E.8.2.4Number of treatment arms in the trial1
    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 concerned12
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 736
    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 state736
    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 Decision2021-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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