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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2021-000001-25
    Sponsor's Protocol Code Number:OXO-001-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-19
    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 number2021-000001-25
    A.3Full title of the trial
    A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study assess the ongoing pregnancy rate with an Investigational Medicinal Product in woman undergoing a donor oocyte IVF/ICSI.
    A.3.2Name or abbreviated title of the trial where available
    OXOART 2 (OXO-001 in Assisted Reproductive Technology, phase 2 trial)
    A.4.1Sponsor's protocol code numberOXO-001-201
    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 SponsorOxolife S.L.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOxolife S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOxolife S.L.
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressC/Nou no. 46
    B.5.3.2Town/ citySant Quirze del Vallès
    B.5.3.3Post code08192
    B.5.3.4CountrySpain
    B.5.4Telephone number+34609771937
    B.5.6E-mailinfo@oxolife.com
    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 No
    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 nameSodium tungstate
    D.3.2Product code OXO-001 (100 mg)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Tungstate
    D.3.9.1CAS number 13472-45-2
    D.3.9.2Current sponsor codeOXO-001
    D.3.9.3Other descriptive nameSodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W-labeled
    D.3.9.4EV Substance CodeSUB181898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 No
    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 nameSodium Tungstate
    D.3.2Product code OXO-001 (150 mg)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Tungstate
    D.3.9.1CAS number 13472-45-2
    D.3.9.2Current sponsor codeOXO-001
    D.3.9.3Other descriptive nameSodium tungstate(VI); Sodium tungstate(VI) Dihydrate ; Sodium tungstate(VI), 181W-labeled
    D.3.9.4EV Substance CodeSUB181898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboFilm-coated tablet
    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
    Infertility treatment and fertility enhancer in women undergoing assisted reproductive techniques or natural reproduction
    E.1.1.1Medical condition in easily understood language
    Female Infertility and Improvemet of fertility
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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 primary objective of this trial is to assess the efficacy of oral OXO-001 (200 mg and 300 mg) versus placebo taken once-daily to increase the ongoing pregnancy rate (defined as the rate of intrauterine pregnancy with foetal heartbeat) at 10 weeks post embryo transfer (ET)
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to assess the efficacy of OXO-001 (200 mg and 300 mg) versus placebo in terms of biochemical pregnancy rate and pregnancy loss rate until 10 weeks post ET and to assess the safety and tolerability of OXO-001 (200 mg and 300 mg) from the first administration until 10 weeks post ET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Voluntary written informed consent before initiation of any trial-related procedures, including the agreement to participate in the pregnancy and infant follow-up if becoming pregnant.
    2. Infertile female subjects indicated for egg donor programme in the context of ART. Infertility is defined as the failure to achieve a clinical pregnancy after:
    a. at least 12 months of regular unprotected sexual intercourse, if < 35 years of age,
    b. at least 6 months of regular unprotected sexual intercourse, if ≥ 35 years of age.
    3. Subjects aged ≥ 18 to ≤ 45 years at screening.
    4. Body mass index (BMI) ≥ 18.0 and < 30.0 kg/m2.
    5. Normal results of a 2-dimensional (2D) or 3-dimensional (3D) transvaginal US (TVUS) at screening (no presence of gynaecological abnormality suspected to affect the ART procedure and outcome). The TVUS should have been performed in the mid of the second part of a menstrual cycle. .
    6. Planned transfer of a fresh single blastocyst from a donated egg.
    7. Good quality sperm (fresh or frozen) available from partner or donor. Sperm assessment must not be older than 6 months prior to screening (fresh and frozen sperm).
    NOTE: The partner’s consent on the review of his medical source data to assess sperm quality and for the potential use of donor sperms, as applicable, is required.
    8. Planned endometrial preparation (not natural) and luteal support.
    E.4Principal exclusion criteria
    1. History of failed IVF/ICSI cycles with donor oocyte (each embryo transfer counts as a cycle). As an exception subjects with one previous failed cycle with donor oocyte are eligible only if this resulted in a confirmed biochemical pregnancy (positive B-human chorionic gonadotropin (B-hCG) test) during that cycle.
    2. Gynaecological abnormality relevant to the ART procedure and outcome, which in the opinion of the investigator could interfere with the trial objectives (e.g. significant uterine anomaly, communicating hydrosalpinx or submucosal/intramural fibroid(s) that deform the uterine cavity, congenital malformations) documented during transvaginal sonography.
    3. Abnormal haemorrhage of the reproductive tract of undetermined origin.
    4. Endometrial biopsy or endometrial local injury within one month prior to screening.
    5. Diagnosis of severe endometriosis (stage III or IV) and/or adenomyosis.
    6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
    7. Relevant clinically significant abnormality in the results of safety laboratory tests at screening.
    8. Systemic disease (e.g. diabetes, epilepsy, severe migraine, hepatic, renal or cardiovascular disease, severe oral corticosteroid-dependent asthma, autoimmune disease, thrombophilia disease) which might interfere with the purpose of the trial.
    9. Any malignant neoplasm.
    10. Known history of venous thrombosis or thromboembolism, including any coagulation abnormality leading to an increased risk of clotting.
    11. History of uncontrolled hypertension.
    12. Known hypersensitivity to any component of the IP used in this trial.
    13. Known allergy, hypersensitivity or any other contraindications to preparations used in the context of endometrial preparation and fresh ET with a donated egg.
    14. History (within 12 months) of or known current problems with alcohol or substance abuse.
    15. Any condition or treatment that, in the opinion of the investigator, may jeopardise the trial conduct according to the protocol.
    16. Previous treatment with the IP of this trial at any time or participation in another clinical trial within the past 3 months prior to screening.
    17. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the principal investigator.
    18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be assessed using the ongoing pregnancy rate, defined as the rate of subjects with uterine pregnancy and a foetal heartbeat, confirmed by ultrasound (US) at 10 weeks post embryo transfer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the main part of the trial.
    E.5.2Secondary end point(s)
    1. Percentage of women with positive blood pregnancy test 10 to 15 days post ET.
    2. Percentage of women with vital pregnancy (defined as intra-uterine pregnancy with foetal heartbeat) at 6 weeks post ET.
    3. Early pregnancy loss rate within 10 weeks of gestation (i.e. after positive blood pregnancy test 10 - 15 days post ET).
    4. Incidence and severity of AEs/ SAEs, reported during the period from the first intake of the IP until 10 weeks post ET.
    5. Changes from baseline in haematology and biochemistry values 6 weeks post ET.
    6. Changes from baseline in vital signs (heart rate, blood pressure).
    7. Changes in endometrial thickness.
    8. Proportion of subjects achieving the endometrial criteria to undergo ET.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the main part of the trial.
    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 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) 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 (main part of the trial)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 351
    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 351
    F.4.2.2In the whole clinical trial 351
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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