Nordic Luveris Study

NCT ID: NCT00553293

Last Updated: 2007-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-11-30

Brief Summary

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To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Detailed Description

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Conditions

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Infertility In Vitro Fertilization

Keywords

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infertility in vitro fertilization LH supplementation Benefits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,1

rFSH + rLH arm

Group Type ACTIVE_COMPARATOR

recombinant luteinizing hormone (Luveris)

Intervention Type DRUG

75 iu/day form cycle day 6

A,2

rFSH alone

Group Type PLACEBO_COMPARATOR

recombinant follicle stimulating hormone (Gonal-f)

Intervention Type DRUG

rFSH 150 iu/day

Interventions

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recombinant luteinizing hormone (Luveris)

75 iu/day form cycle day 6

Intervention Type DRUG

recombinant follicle stimulating hormone (Gonal-f)

rFSH 150 iu/day

Intervention Type DRUG

Other Intervention Names

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Luveris Gonal-f

Eligibility Criteria

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Inclusion Criteria

* Age below 40
* Infertility treatable by IVF or ICSI
* Regular cycles

Exclusion Criteria

* NA
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

Turku Hospital

UNKNOWN

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Holbaek Sygehus

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Anders N Andersen, professor

Role: PRINCIPAL_INVESTIGATOR

Fertility Clinic Rigshospitalet

Locations

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Anders Nyboe Andersen

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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NyboeAndersen A, Humaidan P, Fried G, Hausken J, Antila L, Bangsboll S, Rasmussen PE, Lindenberg S, Bredkjaer HE, Meinertz H; Nordic LH study group. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial. Hum Reprod. 2008 Feb;23(2):427-34. doi: 10.1093/humrep/dem317. Epub 2007 Nov 16.

Reference Type DERIVED
PMID: 18024487 (View on PubMed)

Other Identifiers

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KF02-035/03

Identifier Type: -

Identifier Source: org_study_id