Condition category
Urological and Genital Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
10/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof R. Homburg

ORCID ID

Contact details

VU University Medical Center
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR546; 03/159

Study information

Scientific title

Acronym

Luveris study

Study hypothesis

The hypothesis of this study is that the addition of recLH (Luveris) to a protocol of recFSH (Gonal-F) and GnRH antagonist (Cetrotide) will improve the pregnancy rates in women over the age of 35 years undergoing IVF/ET.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Subfertility

Intervention

Patients will receive a standard protocol of Gonal-F (follitropine; 225 IU/day) from cycle day 2-4 and Cetrotide (Cetrorelix; 0.25 mg/day) from day 6 of stimulation. They will be randomized on day 6 of stimulation to receive either Gonal-F and Luveris (150 IU/day) or continue with Gonal-F alone. In both cases, the dose of Gonal-F will remain unchanged. As in our standard treatment protocol, human choronic gonadotropin (hCG) (Pregnyl) will be given when at least 3 follicles reach 16 mm and ovum collection, embryo replacement and luteal support with vaginal progesterone will all be applied as in our routine IVF procedures.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pregnancy rate/embryo transfer
2. Implantation rate (hCG measurement 15 days after ovum pick up)

Secondary outcome measures

1. Number of follicles >15 mm on day hCG
2. Number of ova collected

Overall trial start date

01/01/2006

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Age >35 years undergoing IVF or intracytoplasmic sperm injection (ICSI) for any indication

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant exclusion criteria

Women with polycystic ovary syndrome (PCOS)

Recruitment start date

01/01/2006

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Gynaecology Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23838159

Publication citations

  1. Results

    König TE, van der Houwen LE, Overbeek A, Hendriks ML, Beutler-Beemsterboer SN, Kuchenbecker WK, Renckens CN, Bernardus RE, Schats R, Homburg R, Hompes PG, Lambalk CB, Recombinant LH supplementation to a standard GnRH antagonist protocol in women of 35 years or older undergoing IVF/ICSI: a randomized controlled multicentre study., Hum. Reprod., 2013, 28, 10, 2804-2812, doi: 10.1093/humrep/det266.

Additional files

Editorial Notes