Nordic Luveris Study

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: In Vitro Fertilization; Infertility

Treatments: Drug: recombinant follicle stimulating hormone (Gonal-f); Drug: recombinant luteinizing hormone (Luveris)

Study type: Interventional

Funder types: Other

Identifiers

NCT00553293

KF02-035/03

Details and patient eligibility

About

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.

Enrollment: 526 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• NA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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526 participants in 2 patient groups, including a placebo group

A,1

Active Comparator group

Description:

rFSH + rLH arm

Treatment:

Drug: recombinant luteinizing hormone (Luveris)

A,2

Placebo Comparator group

Description:

rFSH alone

Treatment:

Drug: recombinant follicle stimulating hormone (Gonal-f)