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Does the addition of recLH (Luveris) to a regimen of recFSH (Gonal-F) and GnRH antagonist (Cetrotide) improve ovarian response and implantation rates in patients age >35 years undergoing IVF/ET?


- candidate number1889
- NTR NumberNTR546
- ISRCTNISRCTN10841210
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR13-dec-2005
- Secondary IDs03/159 
- Public TitleDoes the addition of recLH (Luveris) to a regimen of recFSH (Gonal-F) and GnRH antagonist (Cetrotide) improve ovarian response and implantation rates in patients age >35 years undergoing IVF/ET?
- Scientific TitleDoes the addition of recLH (Luveris) to a regimen of recFSH (Gonal-F) and GnRH antagonist (Cetrotide) improve ovarian response and implantation rates in patients age >35 years undergoing IVF/ET?
- ACRONYMLuveris study
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteriaAge >35 years undergoing IVF or ICSI for any indication.
- Exclusion criteriaWomen with PCOS.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2010
- Target number of participants600
- InterventionsPatients will receive a standard protocol of Gonal-F (follitropine; 225IU/day) from cycle day 2-4 and Cetrotide (Cetrorelix; 0.25mg/day) from day 6 of stimulation. They will be randomized on day 6 of stimulation to receive either Gonal-F and Luveris (150IU/day) or continue with Gonal-F alone. In both cases, the dose of Gonal-F will remain unchanged. As in our standard treatment protocol, hCG (Pregnyl) will be given when at least 3 follicles reach 16mm and ovum collection, embryo replacement and luteal support with vaginal progesterone will all be applied as in our routine IVF procedures.
- Primary outcome1. Pregnancy rate/embryo transfer; 2. Implantation rate (hCG measurement 15 days after ovum pick up).
- Secondary outcome1. Number of follicles >15mm on day hCG; 2. Number of ova collected.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. R. Homburg
- CONTACT for SCIENTIFIC QUERIESProf. R. Homburg
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Gynaecologie (SWOG)
- PublicationsN/A
- Brief summaryA prospective, randomized, open study. Patients over the age of 35 years undergoing a standard IVF or ICSI protocol of recombinant FSH (follitropine, Gonal-F, 225IU/day) from cycle day 2-4 and GnRH antagonist (Cetrotide, 0.25mg/day) from day 6 of stimulation will be randomized on day 6 of stimulation to receive either Gonal-F and recombinant LH (Lutropine, Luveris, 150IU/day) or continue with Gonal-F alone.
- Main changes (audit trail)
- RECORD13-dec-2005 - 6-mrt-2006


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