No registrations found.
Source
Brief title
Health condition
Subfertile women undergoing IVF or ICSI, age > 35 years
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
1. Pregnancy rate/embryo transfer;
2. Implantation rate (hCG measurement 15 days after ovum pick up).
Secondary outcome
1. Number of follicles >15mm on day hCG;
2. Number of ova collected.
Background summary
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.
Study objective
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.
Intervention
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.
P.O. Box 7057
R. Homburg
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl
P.O. Box 7057
R. Homburg
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl
Inclusion criteria
Age >35 years undergoing IVF or ICSI for any indication.
Exclusion criteria
Women with PCOS.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL504 |
NTR-old | NTR546 |
Other | : 03/159 |
ISRCTN | ISRCTN10841210 |