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Summary
EudraCT Number:2004-001124-20
Sponsor's Protocol Code Number:PCOS 5
National Competent Authority:Sweden - MPA
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2005-04-06
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
A. Protocol Information
A.1Member State ConcernedSweden - MPA
A.2EudraCT number2004-001124-20
A.3Full title of the trial
Metformin treatment before IVF/ICSI in non obese women with polycystic ovarian syndrome . A European, prospective, randomised, double-blind, multicenter study.
(MET-AR study )
A.3.2Name or abbreviated title of the trial where available
MET-AR study. Metformin in assisted reproduction.
A.4.1Sponsor's protocol code numberPCOS 5
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorSigrun Kjøtrød
B.1.3.4CountryNorway
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 support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
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 Information not present in EudraCT
D.2.1.1.1Trade name Metformin
D.2.1.1.2Name of the Marketing Authorisation holderMeda
D.2.1.2Country which granted the Marketing AuthorisationSweden
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
D.3.2Product code Metformin
D.3.4Pharmaceutical form Coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
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 Information not present in EudraCT
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 placeboCoated 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
Polycystic ovary syndrome (PCOS) is a disorder characterized by polycystic ovaries, oligo-amenorrea and hyperandogenism. It is the most common endocrine disorder in women of fertile age. PCOS women are an- or oligoovulatory and often suffer from infertility or subfertility. Prevalence estimates vary between three and twenty percent depending on the diagnostic criteriae used, and the population studied. A prevalence of five to seven percent has been reprted in Caucasian women.
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
Does Metformin treatment before IVF/ICSI in non obese (BMI below 28 kg/m2) women with polycystic ovarian syndrome increase clinical pregnancy rate in IVF/ICSI?
Clinical pregnancy rate is defined as a verified intrauterine gestational sack by ultrasound week seven of pregnancy.
E.2.2Secondary objectives of the trial
-Number of oocytes collected and embryo quality
-Dose of gonadotrophin, both daily and total used in IVF/ICSI cycle (ie costs of treatment) Also number of days of gonadotrophin treatment.
-s-Estradiol on day of hCG-injection, and occurrence of ovarian hyperstimulation syndome (OHSS)
-Spontaneous pregnancy rates during pretreatment period (ie before IVF/ICSI)
-Spontaneous abortion rates and finally live birth rates.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
--PCOS diagnosis based on the ESHRE/ASRM (Rotterdam may 03) criteria;-fulfilling at least two of the following three criteria - Oligo-amenorrea, hyperandrogenism and/or
PCO-ovaries by ultrasound.
-More than one year of infertility in PCOS women planned for IVF or ICSI
-First or second cycle of IVF or ICSI-treatment
-Age below 38 years at inclusion
-BMI below 28 kg/m2 at inclusion
-Patient willing to be randomised for 4 months treatment with metformin or placebo
-If previously on metformin, a one month wash-out period is required.
E.4Principal exclusion criteria
-More than one previous IVF-cycle
-Patients not suitable for starting dose 112.5 IE of Gonal F
-Basal-FSH above 10 IE
-Known liver disease or s-ALAT above 80 IU/L
-Known renal disease or s-Creatinine above above 110 mmol/l
-Known alcoholism or drug abuse
-Known diabetes mellitus, or fasting plasma-glucose above 7.0 mmol/L (= fasting whole blood glucose above 6.1 mmol/L)
-Peroral steroid hormone treatment
-Treatment with cimetidin, anticoaguantia, erythromycin or other macrolides
-Hyperprolactinemia or s-PRL above 700 IE/L
-Abnormal thyroid function tests
-Congenital adrenal hyperplasia
-Androgen secreting tumours
-Cushing disease
-Unfit to participate of any other reason
E.5 End points
E.5.1Primary end point(s)
Clinical pregnancy rate following IVF or ICSI treatment in non obese PCOS women.
Clinical pregnancy rate defined by an intrauterine gestational sack week 7 in pregnancy
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
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 Information not present in EudraCT
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 Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
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 No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Multicenter trial
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States Yes
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 Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
Last visit in the IVF-unit will be ultrasound week seven in pregnancy.
In addition live birth rates, birth weight, gestational week (premature births),
late abortions and both major and minor malformations diagnosed at birth will
be reported.
So the study is not finished until the last pregnant patient has given birth.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years3
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
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 Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-04-06. Yes
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
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 state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 300
F.4.2.2In the whole clinical trial 300
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)
If pregnant- following common pregnancy care and controls.
If not pregnant- according to the individual IVF clinics policy (new IVF/ICSI cycle)
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 Decision2005-06-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2005-04-22
P. End of Trial
P.End of Trial StatusCompleted

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