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.
Bron
Verkorte titel
Aandoening
Subfertile women undergoing IVF or ICSI, age > 35 years
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
1. Pregnancy rate/embryo transfer;
2. Implantation rate (hCG measurement 15 days after ovum pick up).
Achtergrond van het onderzoek
A 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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
P.O. Box 7057
R. Homburg
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl
Wetenschappelijk
P.O. Box 7057
R. Homburg
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age >35 years undergoing IVF or ICSI for any indication.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Women with PCOS.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL504 |
NTR-old | NTR546 |
Ander register | : 03/159 |
ISRCTN | ISRCTN10841210 |