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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23838159
Publication citations
-
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.