Does the addition of Recombinant Luteinising Hormone (recLH) (Luveris) to a regimen of Recombinant Follicle Stimulating Hormone (recFSH) (Gonal-F) and Gonadotropin Releasing Hormone (GnRH) antagonist (Cetrotide) improve ovarian response and implantation rates in patients age >35 years undergoing in vitro fertilisation (IVF)/embryo transfer (ET)?
| ISRCTN | ISRCTN10841210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10841210 |
| Protocol serial number | NTR546; 03/159 |
| Sponsor | VU University Medical Centre (VUMC) (Netherlands) |
| Funder | Gynaecology Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG]) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 10/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof R. Homburg
Scientific
Scientific
VU University Medical Center
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 4440070 |
|---|---|
| R.homburg@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Luveris study |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Pregnancy rate/embryo transfer |
| Key secondary outcome measure(s) |
1. Number of follicles >15 mm on day hCG |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 600 |
| Key inclusion criteria | Age >35 years undergoing IVF or intracytoplasmic sperm injection (ICSI) for any indication |
| Key exclusion criteria | Women with polycystic ovary syndrome (PCOS) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
