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    Summary
    EudraCT Number:2022-002310-16
    Sponsor's Protocol Code Number:LHinPOR001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-12-06
    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 number2022-002310-16
    A.3Full title of the trial
    Endometrial gene expression profiles during ovarian stimulation with recombinant
    human FSH with or without the addition of recombinant human LH in genuine poor responders.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the function of the endometrium during IVF/ICSI in patients with a low ovarian reserve, comparing two different types of ovarian stimulation.
    A.3.2Name or abbreviated title of the trial where available
    ELIPSe trial (Endometrial gene expression with LH addition In Poor ovarian responderS)
    A.4.1Sponsor's protocol code numberLHinPOR001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05405686
    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 SponsorUZ Brussel
    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 supportMerck N.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointStudy Team
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number003224776648
    B.5.6E-mailStudieverpleegkundigen_CRG@uzbrussel.be
    D. IMP Identification
    D.IMP: 1
    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 Gonal-F
    D.2.1.1.2Name of the Marketing Authorisation holderMerck N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFollitropin alfa
    D.3.9.1CAS number 56832-30-5
    D.3.9.4EV Substance CodeSUB12426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name Pergoveris
    D.2.1.1.2Name of the Marketing Authorisation holderMerck N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLutropin alfa
    D.3.9.1CAS number 152923-57-4
    D.3.9.4EV Substance CodeSUB12524MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number312.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFollitropin alfa
    D.3.9.1CAS number 56832-30-5
    D.3.9.4EV Substance CodeSUB12426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number625
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    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
    The purpose of this trial is to assess the differences in endometrial gene expression profiles of ovarian stimulation with recombinant hFSH versus both recombinant hFSH and hLH in poor responder patients
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the differences in histologic analysis of the endometrium, based on the Noyes’ criteria.
    - To evaluate if there is a difference in the number of preovulatory follicles, number of MII oocytes, number of oocytes fertilized, number of good quality embryos and total dose of gonadotropins administered.
    - To compare clinical outcomes in both groups, including implantation rate, clinical pregnancy rate and live birth rate.

    The exploratory objectives are
    - To study the differences of genes expression of cumulus cells (CC) be-tween both stimulation groups using full transcriptome analysis.
    - To study the differences of gene expression of cumulus cells in relation to embryo development using the same transcriptome data.
    - To evaluate the effect of LH supplementation on the endocrine profile in blood and follicular fluid (FF)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subfertility/infertility
    Age ≥35 ≤ 40 years
    Undergoing ICSI
    BMI ≥ 19 and ≤ 30 kg/m²
    AMH <1.2 ng/mL
    Previous conventional ovarian stimulation (OS) with < 4 metaphase II (MII) oocytes
    Regular menstrual cycle (26-35 days)
    Non-smokers
    Acceptance to do two consecutive ovarian stimulation cycles (between 1-6 months)
    Signed informed consent
    E.4Principal exclusion criteria
    Endometriosis > rAFS grade II
    Testicular sperm extraction
    Recurrent miscarriage (>2 previous miscarriages)
    Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
    Medical/social oocyte vitrification
    In vitro maturation (IVM)
    Untreated auto-immune, endocrine, or metabolic disorders
    Asherman’s syndrome
    Medical history of coagulopathies
    Severe OHSS in a previous treatment cycle
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the endometrial gene expression profile (using RNAseq) on the 7th day after oocyte maturation trigger .
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Gene expression analysis will occur once all samples have been collected.
    E.5.2Secondary end point(s)
    • Endometrial histologic analysis based on Noyes’ classification system
    • Progesterone and oestradiol level at oocyte triggering
    • Number of preovulatory follicles
    • Number of MII oocytes
    • Number of fertilized oocytes
    • Number of good quality embryos
    • Total dose of gonadotropins administered
    • Duration of stimulation
    • Endometrial thickness at the day of endometrial biopsy
    • Implantation rate
    • Clinical pregnancy rate
    • Live birth rate
    • Cumulus cell (CC) gene expression.
    • Follicular fluid (FF) endocrine analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 months
    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 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) 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    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: 36
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state36
    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 Decision2022-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-10
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