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
Secondary identifying numbers	NTR546; 03/159

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

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
Email	R.homburg@vumc.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/01/2006
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

Sponsor information

VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

Gynaecology Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG])

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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