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Nordic Luveris Study

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00553293
Collaborator
Regionshospitalet Viborg, Skive (Other), Karolinska University Hospital (Other), Helse Fonna (Other), Turku Hospital (Other), Odense University Hospital (Other), Herlev Hospital (Other), Holbaek Sygehus (Other), Hvidovre University Hospital (Other)
526
Enrollment
1
Location
2
Arms
15
Duration (Months)
35
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: recombinant luteinizing hormone (Luveris)
  • Drug: recombinant follicle stimulating hormone (Gonal-f)
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
526 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial
Study Start Date :
Aug 1, 2003
Actual Study Completion Date :
Nov 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A,1

rFSH + rLH arm

Drug: recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
Other Names:
  • Luveris

    		•
    Placebo Comparator: A,2

    rFSH alone

    Drug: recombinant follicle stimulating hormone (Gonal-f)
    rFSH 150 iu/day
    Other Names:
  • Gonal-f

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ongoing pregnancy rate per started stimulation cycle [ultrasound showing ongoing pregnancy]

    Secondary Outcome Measures

    1. Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ultrasound for ongoing pregnancy in subgroups]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age below 40

    • Infertility treatable by IVF or ICSI

    • Regular cycles

    Exclusion Criteria:
    • NA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anders Nyboe Andersen Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • Regionshospitalet Viborg, Skive
    • Karolinska University Hospital
    • Helse Fonna
    • Turku Hospital
    • Odense University Hospital
    • Herlev Hospital
    • Holbaek Sygehus
    • Hvidovre University Hospital

    Investigators

    • Principal Investigator: Anders N Andersen, professor, Fertility Clinic Rigshospitalet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00553293
    Other Study ID Numbers:
    • KF02-035/03
    First Posted:
    Nov 4, 2007
    Last Update Posted:
    Nov 4, 2007
    Last Verified:
    Nov 1, 2007
    Keywords provided by , ,
    infertility
    in vitro fertilization
    LH supplementation
    Benefits
    Additional relevant MeSH terms:
    Infertility
    Hormones
    Follicle Stimulating Hormone

    Study Results

    No Results Posted as of Nov 4, 2007