Plain English Summary
Background and study aims
In vitro fertilisation (IVF) is one of several techniques available to help people with fertility problems to have a baby. Gonadotrophins are medicines used in IVF to stimulate ovulation (the monthly release of an egg). Elonva is a new, long acting gonadotropin. As Elonva is a long acting gonadotropin, only one injection is needed instead of one injection every day, but the dosage cannot be adapted as with daily injections. The aim of this study is to compare Elonva with another gonadotropin that is routinely used in IVF (Puregon).
Who can participate?
Women younger than 40 undergoing a second IVF cycle
What does the study involve?
Participants are randomly allocated to be treated with either Elonva or Puregon. The pregnancy rate, number of eggs retrieved, doses of gonadotropins used and days of stimulation needed are compared between the two groups.
What are the possible benefits and risks of participating?
A possible benefit of participating in this study is patient comfort because they will only need one injection instead of daily injections with Puregon. A possible risk is a different pregnancy rate or number of eggs although previous studies do not show this.
Where is the study run from?
1. H. Hart hospital, Leuven, Belgium
2. ZOL (ziekenhuis post-Limburg), Genk, Belgium
When is the study starting and how long is it expected to run for?
March 2012 to April 2013
Who is funding the study?
Leuven Institute for Fertility and Embryology (Belgium)
Who is the main contact?
Dr Stephan Gordts
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial comparing Puregon® and Elonva® both in a GnRH agonist protocol for IVF stimulation
Acronym
Study hypothesis
Elonva® is a long acting gonatropin that can be used for IVF stimulation. If similar pregnancy and live birth rates can be achieved, this could give more comfort for the patients.
Ethics approval
Not provided at time of registration
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Female infertility
Intervention
Both groups: Decapeptyl® SR, between day 21 and day 25 of the cycle. Ultrasound control after 2 weeks.
Group 1: Start of Puregon® on day of scan. Ultrasound and blood test after 5 days of stimulation with option of adapting the dosage.
Group 2: Injection of Elonva® on day of scan. Ultrasound and blood test on day 8 with evaluation of further stimulation is needed.
For both groups: As soon as follicles on scan are larger than 17 mm, Pregnyl® will be given and oocyte pick-up will be planned 35 hours after injection of Pregnyl®. Embryo transfer will be performed according to the Belgian legislation.
Intervention type
Drug
Phase
Not Applicable
Drug names
Decapeptyl®, Elonva®, Pregnyl®, Puregon®
Primary outcome measure
Pregnancy rate
Secondary outcome measures
1. Days of stimulation needed
2. Doses of gonadotropins used
3. Number of oocytes retrieved
4. Fertilization rate
5. Number of embryos for cryopreservation
Overall trial start date
01/03/2012
Overall trial end date
01/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Second IVF attempt
2. Younger than 40 years
3. Anti-mullerian hormone less than 3
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
160
Participant exclusion criteria
1. Previous cycle ovarian hyper stimulation syndrome
2. Pre-implantation genetic diagnosis cycles
3. IVF cycles using testicular sperm biopsy
4. Patients needing more than 2500 U of gonadotropins in the first cycle
5. Patients above 40 years
Recruitment start date
01/03/2012
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Belgium
Trial participating centre
Leuven Institute for Fertility and Embryology
Leuven
3000
Belgium
Sponsor information
Organisation
Leuven Institute for Fertility and Embryology [LIFE] (Belgium)
Sponsor details
Tiensevest 168
Leuven
3000
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leuven Institute for Fertility and Embryology [LIFE] (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list