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Nordic Luveris Study

Primary Purpose

Infertility, In Vitro Fertilization

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

recombinant luteinizing hormone (Luveris)

recombinant follicle stimulating hormone (Gonal-f)

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, in vitro fertilization, LH supplementation, Benefits

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age below 40
Infertility treatable by IVF or ICSI
Regular cycles

Exclusion Criteria:

Sites / Locations

Anders Nyboe Andersen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A,1

A,2

Arm Description

rFSH + rLH arm

rFSH alone

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate per started stimulation cycle

Secondary Outcome Measures

Ongoing pregnancy in subgroups of patients with lo0w serum LH levels

Full Information

NCT ID

NCT00553293

First Posted

November 2, 2007

Last Updated

November 2, 2007

Sponsor

Rigshospitalet, Denmark

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00553293

Brief Title

Nordic Luveris Study

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 Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

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

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, In Vitro Fertilization

Keywords

infertility, in vitro fertilization, LH supplementation, Benefits

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

526 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A,1

Arm Type

Active Comparator

Arm Description

rFSH + rLH arm

Arm Title

A,2

Arm Type

Placebo Comparator

Arm Description

rFSH alone

Intervention Type

Drug

Intervention Name(s)

recombinant luteinizing hormone (Luveris)

Other Intervention Name(s)

Luveris

Intervention Description

75 iu/day form cycle day 6

Intervention Type

Drug

Intervention Name(s)

recombinant follicle stimulating hormone (Gonal-f)

Other Intervention Name(s)

Gonal-f

Intervention Description

rFSH 150 iu/day

Primary Outcome Measure Information:

Title

Ongoing pregnancy rate per started stimulation cycle

Time Frame

ultrasound showing ongoing pregnancy

Secondary Outcome Measure Information:

Title

Ongoing pregnancy in subgroups of patients with lo0w serum LH levels

Time Frame

ultrasound for ongoing pregnancy in subgroups

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age below 40 Infertility treatable by IVF or ICSI Regular cycles Exclusion Criteria: NA

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders N Andersen, professor

Organizational Affiliation

Fertility Clinic Rigshospitalet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anders Nyboe Andersen

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

18024487

Citation

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.

Results Reference

derived

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Nordic Luveris Study

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