Nordic Luveris Study

Phase 4

Completed

• Conditions: Infertility; In Vitro Fertilization
• Interventions: Drug: recombinant follicle stimulating hormone (Gonal-f); Drug: recombinant luteinizing hormone (Luveris)

• Registration Number: NCT00553293
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study Completion: 2004-11
• Status Verified: 2007-11
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Last Update Submitted: 2007-11-02
• Study First Posted: 2007-11-04
• Last Update Posted: 2007-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 526

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,2	recombinant follicle stimulating hormone (Gonal-f)	rFSH alone
A,1	recombinant luteinizing hormone (Luveris)	rFSH + rLH arm

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate per started stimulation cycle	ultrasound showing ongoing pregnancy

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy in subgroups of patients with lo0w serum LH levels	ultrasound for ongoing pregnancy in subgroups

Trial Locations

Locations (1)

Anders Nyboe Andersen; 🇩🇰 Copenhagen, Denmark