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    Summary
    EudraCT Number:2022-003879-42
    Sponsor's Protocol Code Number:2021/ABM/03/00006
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-003879-42
    A.3Full title of the trial
    A randomized, controlled, double-blind clinical trial evaluating the effect of METformin treatment on endometrial function in women diagnosed with Idiopathic Infertility
    Randomizowane, kontrolowane, podwójnie zaślepione badanie kliniczne oceniające wpływ leczenia METforminą na funkcję endometrium u kobiet z rozpoznaną Idiopatyczną Niepłodnością
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    randomized, controlled, double-blind clinical trial evaluating the effect of METformin treatment on endometrial function in women diagnosed with Idiopathic Infertility
    Badanie efektywności metforminy w leczeniu idiopatycznej niepłodności
    A.3.2Name or abbreviated title of the trial where available
    METIN
    METIN
    A.4.1Sponsor's protocol code number2021/ABM/03/00006
    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 SponsorMedical Univeristy of Bialystok
    B.1.3.4CountryPoland
    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 supportMedical University of Bialystok
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Bialystok
    B.5.2Functional name of contact pointMonika Zbucka-Kretowska
    B.5.3 Address:
    B.5.3.1Street AddressJana Kilinskiego 1
    B.5.3.2Town/ cityBialystok
    B.5.3.3Post code15-089
    B.5.3.4CountryPoland
    B.5.4Telephone number4885748 58 00
    B.5.5Fax number4885748 54 16
    B.5.6E-mailmonika.zbucka-kretowska@umb.edu.pl
    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 Glucophage
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sante s.a.s.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMetformin 500mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Potential causes of idiopathic infertility include in particular: abnormal function of the endometrium, including implantation disorders and immunological abnormalities, genetic abnormalities and the functioning of reproductive cells and embryos, functional abnormalities of reproductive cells and embryos, dysfunctions and discreet anatomical anomalies of the fallopian tubes transport of reproductive cells and embryos.
    Potencjalne podłoże niepłodności idiopatycznej wymienia się w szczególności: nieprawidłową funkcję endometrium, w tym zaburzenia implantacji oraz nieprawidłowości immunologiczne, nieprawidłowości genetyczne i funkcjonowanie komórek rozrodczych i zarodków, nieprawidłowości funkcjonalne komórek rozrodczych i zarodków, zaburzenia funkcji oraz dyskretne anomalie anatomiczne jajowodów (pomimo zachowanej drożności) zaburzające transport komórek rozrodczych oraz zarodków.
    E.1.1.1Medical condition in easily understood language
    Idiopathic infertility is diagnosed after all other medically known symptoms of infertility are excluded. This category includes 5 - 10% of all infertile couples.
    Niepłodność diopatyczną rozpoznaje się po wykluczeniu wszystkich innych medycznie znanych objawów niepłodności. Ta kategoria obejmuje 5 - 10% wszystkich niepłodnych par.
    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 HLT
    E.1.2Classification code 10016471
    E.1.2Term Fertility and fertilisation interventions female
    E.1.2System Organ Class 100000004865
    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 aim of the study is to evaluate the effect of metformin on endometrial function
    in women diagnosed with idiopathic infertility, by proving the use of the proposed therapy to improve fertility in these women.
    Celem badania jest ocena wpływu metforminy na poprawę funkcji endometrium
    u kobiet ze zdiagnozowaną niepłodnością idiopatyczną, poprzez udowodnienie bezpośredniego związku proponowanej terapii z poprawą płodności u tych kobiet.
    E.2.2Secondary objectives of the trial
    1. Evaluation of the effect of metformin therapy on endometrial function.
    It will be tested by assessing the concentration of markers such as: cytokines, IGF, LIF, TGF-α, EGF, HB-EGF, VEGF, histamine, inhibin B, relaxin and insulin receptor in the tissue before and after treatment.
    2. Transcriptome analysis of endometrial tissues (NGS) before and after metformin therapy.
    3. Intratissue metabolomic profiling of steroids.
    The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.
    4. Effect of metformin treatment on the regulation of oxidative stress in the endometrium.

    Additional information will also be provided by the analysis of the Quality of life (QoL) questionnaire of the patients undergoing the study and the analysis of menus combined with the DXA study.
    1. Ocena wpływu terapii metforminą na funkcję endometrium.
    Zostanie ona zbadana poprzez ocenę stężenia markerów takich jak: cytokin, IGF, LIF, TGF-α, EGF, HB-EGF, VEGF, histamina, inhibina B, relaksyna oraz receptor insulinowy w tkance przed i po leczeniu.
    2. Analiza transkryptomu tkanek endometrium (NGS) przed i po terapii metforminą.
    3. Wewnątrztkankowe profilowanie metabolomiczne steroidów.
    Przeprowadzone badanie pozwoli sprawdzić, czy leczenie metforminą wpływa na intrakrynną produkcję hormonów steroidowych w endometrium.
    4. Wpływ leczenia metforminą na regulację stresu oksydacyjnego w endometrium.

    Dodatkowych informacji dostarczy również analiza kwestionariusza jakości życia - Quality of life (QoL) pacjentek poddanych badaniu oraz analiza jadłospisów połączona z badaniem DXA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age ≥20≤40 years.
    2. No occurrence of pregnancy for a minimum of 12 months prior to screening.
    3. Diagnosed idiopathic infertility.
    4. No use of hormonal therapy 30 days prior to screening. 5. No use of any method of contraception 30 days prior to screening and during screening.
    6. BMI between 18.5 - 30 kg/m2.
    7. Eligibility for an in vitro fertilisation programme.
    11. Wiek ≥20≤40 lat.
    2. Brak wystąpienia ciąży przez okres minimum 12 miesięcy przed screeningiem.
    3. Rozpoznane idiopatycznej niepłodności.
    4. Brak stosowania terapii hormonalnej na 30 dni przed screeningiem.
    5. Brak stosowania jakichkolwiek metod antykoncepcji na 30 dni przed screeningiem oraz w trakcie badania.
    6. BMI między 18,5 - 30 kg/m2.
    7. Kwalifikacja do programu pozaustrojowego zapłodnienia.
    E.4Principal exclusion criteria
    1. Positive pregnancy test result.
    2. Patients diagnosed with another infertility factor.
    3. Patients with type I or II diabetes.
    4. Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks prior to screening.
    5. patients with liver dysfunction and abnormal liver function tests (alanine aminotransferase activity and/or aspartate aminotransferase activity (above 3x GGN).
    6. patients with an eGFR below 45 ml/ min/1.73m2.
    7. Accompanying chronic diseases with poor prognosis.
    8. patients with a history of lactic acidosis or other metabolic acidosis.
    9. Patients with a history of congestive heart failure NYHA class III/IV.
    10. patients with acute myocardial ischaemia. 11. patients with sepsis or severe infection.
    12. diseases that, in the opinion of the investigator, constitute an exclusion criterion and preclude the patient's participation in the study.
    13. Patients with foreseeable problems with co-operation with the study team.
    1. Dodatni wynik testu ciążowego.
    2. Pacjentki, u których zdiagnozowano inny czynnik niepłodności.
    3. Pacjentki z cukrzycą typu I lub II.
    4. Pacjentki przyjmujące metforminę lub inne leki hipoglikemizujące w ciągu ostatnich 4 tygodni przed screeningiem.
    5. Pacjentki z zaburzeniami czynności wątroby i nieprawidłowymi wynikami testów czynnościowych wątroby (aktywność aminotransferazy alaninowej i / lub aktywność aminotransferazy asparaginianowej (powyżej 3x GGN).
    6. Pacjentki z eGFR poniżej 45 ml/ min/1,73m2.
    7. Towarzyszące choroby przewlekłe o złym rokowaniu.
    8. Pacjentki z kwasicą mleczanową lub inną kwasicą metaboliczną w wywiadzie.
    9. Pacjentki z zastoinową niewydolnością serca w wywiadzie III/IV stopień wg NYHA.
    10. Pacjentki z ostrym niedokrwieniem mięśnia sercowego.
    11. Pacjentki z posocznicą lub ciężką infekcją.
    12. Choroby, które w opinii badacza stanowią kryterium wyłączenia i uniemożliwiają udział pacjentki w badaniu.
    13. Pacjentki o przewidywalnych problemach ze współpracą z zespołem badawczym.
    E.5 End points
    E.5.1Primary end point(s)
    Obtaining a pregnancy during the study.
    Uzyskanie ciąży w trakcie trwania badania.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ater 57 months
    po 57 miesiącach - po zakończeniu badania
    E.5.2Secondary end point(s)
    .Evaluation of the effect of metformin therapy on endometrial function.
    It will be tested by assessing the concentration of markers such as: cytokines (interleukin-1 and 2), insulin-like growth factor (IGF), leukemia inhibitory factor (LIF), transforming growth factor alpha (TGF-α), epidermal growth factor (EGF), heparin-binding EGF-like growth factor (HB-EGF), vascular endothelial growth factor (VEGF), histamine, inhibin B, relaxin, and insulin receptor in tissue before and after treatment.
    2. Transcriptome analysis of endometrial tissues using Next Generation Sequencing (NGS) technology before and after metformin therapy.
    The transcriptome will be examined, including the microRNA profile, which will allow to assess the mechanisms of metformin action and determine whether microRNAs as gene expression regulators can be diagnostic or predictive markers of endometrial dysfunction.
    3. Intratissue metabolomic profiling of steroids.
    The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.
    4. Effect of metformin treatment on the regulation of oxidative stress in the endometrium.
    In-depth analysis of molecular and cellular processes using multi-omics combined with clinical data will provide the necessary knowledge about the mechanisms of action of metformin, which may also be clinically applicable to both idiopathic female infertility and other conditions.
    Additional information will also be provided by the analysis of the Quality of life (QoL) questionnaire of the patients undergoing the study and the analysis of menus combined with the DXA study.
    .Ocena wpływu terapii metforminą na funkcję endometrium.
    Zostanie ona zbadana poprzez ocenę stężenia markerów takich jak: cytokiny (interleukina-1 i 2), insulinopodobny czynnik wzrostu (IGF), czynnik hamujący białaczkę (LIF), transformujący czynnik wzrostu alfa (TGF-α), naskórkowy czynnik wzrostu (EGF), czynnik wzrostu wiążący heparynę podobny do EGF (HB-EGF), czynnik wzrostu śródbłonka naczyniowego (VEGF), histamina, inhibina B, relaksyna oraz receptor insulinowy w tkance przed i po leczeniu.
    2. Analiza transkryptomu tkanek endometrium w technologii sekwencjonowania następnej generacji (NGS) przed i po terapii metforminą.
    Zbadany zostanie transkryptom włączając profil mikroRNA, co pozwoli na ocenę mechanizmów działania metforminy oraz ustalenie, czy mikroRNA jako regulatory ekspresji genów mogą być markerami diagnostycznymi lub predykcyjnymi zaburzeń funkcji endometrium.
    3. Wewnątrztkankowe profilowanie metabolomiczne steroidów.
    Przeprowadzone badanie pozwoli sprawdzić, czy leczenie metforminą wpływa na intrakrynną produkcję hormonów steroidowych w endometrium.
    4. Wpływ leczenia metforminą na regulację stresu oksydacyjnego w endometrium.
    Dogłębna analiza procesów molekularnych oraz komórkowych z zastosowaniem multi-omiki połączona z danymi klinicznymi dostarczy potrzebnej wiedzy na temat mechanizmów działania metforminy, która może mieć też zastosowanie kliniczne zarówno w przypadku idiopatycznej niepłodności żeńskiej, jak również w innych schorzeniach.
    Dodatkowych informacji dostarczy również analiza kwestionariusza jakości życia - Quality of life (QoL) pacjentek poddanych badaniu oraz analiza jadłospisów połączona z badaniem DXA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 57 months
    po 57 miesiącach - po zakończeniu badania
    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 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 trial3
    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
    Early termination of a study may occur if the primary endpoint is met, patient consent is withdrawn, or due to regulatory decisions or product safety issues.
    Przedwczesne zakończenie badania może nastąpić w przypadku osiągnięcia pierwszorzędowego punktu końcowego, wycofania zgody pacjenta lub powodu decyzji właściwych organów lub problemów związanych z bezpieczeństwem produktu.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days15
    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: 180
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    not applicable
    nie dotyczy
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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