Clinical Trials Register

Summary
EudraCT Number:	2008-008355-42
Sponsor's Protocol Code Number:	2008-257
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-01-07
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2008-008355-42

A.3

Full title of the trial

Supplering med hCG ved kontrolleret ovariel stimulering med rekombinant FSH for in vitro fertilisering
Et randomiseret kontrolleret klinisk studie
Kliniske, embryonale, endokrine og genetiske aspekter

A.4.1

Sponsor's protocol code number

2008-257

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fertilitetsklinikken
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Predalon
D.2.1.1.2	Name of the Marketing Authorisation holder	Organon (Germany)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Predalon
D.3.2	Product code	Zul.-Nr.6085002.00.00
D.3.4	Pharmaceutical form	Injection*
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Choriongonadotropin
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Urinderiveret fra gravide kvinder

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Dette studie er et investigator initieret randomiseret og kontrolleret hCG ”dose-finding” studie, hvor Predalon (hCG) vil blive anvedt som supplering i forskellige doser til stimulationsbehandling af infertile kvinder (IVF).
Doserne er 50I/E, 100I/E og 150I/E.
Vores primære endpoint er embryoner af top kvailitet.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10021926
E.1.2	Term	Infertility

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Med studiet ønskes at definere den optimale mængde LH aktivitet (hCG) ved kontrolleret ovariel stimulation, som meget vel kan være højere end den dosis, der i øjeblikket anvendes. Det er vigtigt et at fastlægge en øvre grænse, dvs. en dosis over hvilken, der forventes ikke at være en yderligere positiv effekt.
Vores primære endpoint er embryoner af top kvalitet.
Undersøgelsen vil endvidere give betydelig viden om de fysiologiske virkninger af hCG gennem analyse af follikelvæske, granulosa og cumulus celler.
Det ultimative mål er at bidrage med oplysninger, som kan optimere vores FSH/LH (hCG) stimulations protokoller for IVF og dermed at øge graviditetsraten.

E.2.2

Secondary objectives of the trial

Sekundære endpoints er:
Follikeludvikling
Antal aspirerede oocytter
Antal fertiliserede oocytter
Fertiliserings rate
Antal transferede embryoner
Implantations rate
Varighed af stimulationen
Anvendt rFSH dosis
Serumniveau af endokrine parametre, inklusiv hCG
Endometrie status
Klinisk graviditet (GA uge 7-8)
Igangværende graviditet (GA uge 10-12)
Aborter, inklusiv biokemiske graviditeter
Follikelvæske niveauer af endokrine parametre og cytokiner
Gen-ekspression på granulosa celler og cumulus celler
Udvikling af embryoner fra forskellige follikelstørrelser
Forhold mellem folliklens endokrine miljø og betydningen af embryon udvikling

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inklusionskriterier
1. Kvinder med indikation for COS og IVF;
2. Alder mellem 25-37 år;
3. BMI> 18 og <30 kg/m2;
4. Normal menstruationscykluslængde på 24-35 dage, som formodes at være ovulatorisk;
5. To ovarier;
6. Tubafaktor eller uforklaret infertilitet, herunder endometriose stadium I/II;
7. Uterus med forventet normal funktion (f.eks. ingen klinisk betydende fribromer) dokumenteret ved ultralydsscanning ved screening;
8. Mandlig partner med sædkvalitet forenelig med befrugtning via IVF eller tidligere klinisk graviditet;
9. FSH-niveauer på 1-12 IE/L i tidlig follikulær fase;
10. Totalt antal antrale follikler (2-10mm) ≥6 i tidlig follikulær fase;
11. Bekræftelse af nedregulering ved ultralydsscanning;
12. Villig og i stand til at underskrive informeret samtykke

E.4

Principal exclusion criteria

Ekslusionskriterier
1. Anamnese med aktuel PCOS, endometriose stadium III/IV eller svær mandlig faktor, som kræver ICSI;
2. Anamnese med svær ovarielt hyperstimulationssyndrom;
3. Tilstedeværelse af hydrosalpinx ved ultralydsscanning;
4. Mere end tre tidligere COS cykli;
5. Tidligere dårlig respons på en IVF-cyklus defineret som > 20 dages gonadotropin stimulation, aflysning på grund af begrænset follikelrespons eller mindre end fire follikler med en diameter ≥15 mm;
6. Tidligere IVF cyklus med ikke succesfuld fertilisering defineret som fertilisering af ≤20% af de aspirerede oocytter;
7. Anamnese med tilbagevendende aborter;
8. FSH > 12 IE/L eller LH > 12 IE/L (i tidlig follikulær fase);
9. Kontraindikationer for anvendelse af gonadotropiner eller GnRH analoger;
10. Anamnese med aktuel epilepsi, HIV infektion, diabetes eller kardiovaskular, gastrointestinal, hepatisk, renal eller pulmonal sygdom;
11. Graviditet, amning eller kontraindikation for graviditet;
12. Nuværende eller tidligere (seneste 12 måneder) misbrug af alkohol eller narkotika;
13. Anamnese med kemoterapi (undtagen gesationelle årsager) og strålebehandling;
14. Udiagnosticeret vaginalblødning;
15. Tumorer i ovarier, mammae, binyre, hypofyse eller hypothalamus og misdannelser af kønsorganerne, uforenelig med graviditet;

E.5 End points

E.5.1

Primary end point(s)

Primære endpoint
Det primære endpoint er det samlede antal top kvalitets embryoner på dag 3.
Top kvalitets embryoner er defineret som: fire til fem blastomerer dag 2, syv eller flere blastomerer dag 3, samme størrelse blastomerer og £20% fragmentering dag 3 og ingen multinucleation.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial 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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-01-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-08-01

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