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NCT00553293 Clinical Trial

Nordic Luveris Study

Infertility Clinical Trial

Official title:
Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00553293
Other study ID # KF02-035/03
Secondary ID
Status Completed
Phase Phase 4
First received November 2, 2007
Last updated November 2, 2007
Start date August 2003
Est. completion date November 2004

Study information
Verified date November 2007
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 526
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 40 Years
Eligibility Inclusion Criteria:

- Age below 40

- Infertility treatable by IVF or ICSI

- Regular cycles

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
• recombinant follicle stimulating hormone (Gonal-f)
rFSH 150 iu/day

Locations
Country Name City State
Denmark Anders Nyboe Andersen Copenhagen

Sponsors (9)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Helse Fonna, Herlev Hospital, Holbaek Sygehus, Hvidovre University Hospital, Karolinska University Hospital, Odense University Hospital, Regionshospitalet Viborg, Skive, Turku Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ongoing pregnancy rate per started stimulation cycle ultrasound showing ongoing pregnancy
Secondary Ongoing pregnancy in subgroups of patients with lo0w serum LH levels ultrasound for ongoing pregnancy in subgroups
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