Comparison study of Puregon® and Elonva® used in a long gonadotropin-releasing hormone (GnRH) agonist protocol for IVF stimulation

ISRCTN	ISRCTN98623456
DOI	https://doi.org/10.1186/ISRCTN98623456
Secondary identifying numbers	N/A

Submission date: 20/02/2012
Registration date: 27/03/2012
Last edited: 21/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Stephan Gordts
Scientific

Leuven Institute for Fertility and Embryology
Tiensevest 168
Leuven
3000
Belgium

Study information

Study design	Prospective randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial comparing Puregon® and Elonva® both in a GnRH agonist protocol for IVF stimulation
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/03/2012
Completion date	01/04/2013
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	160
Key inclusion criteria	1. Second IVF attempt 2. Younger than 40 years 3. Anti-mullerian hormone less than 3
Key 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
Date of first enrolment	01/03/2012
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Belgium

Study participating centre

Leuven Institute for Fertility and Embryology

Leuven
3000
Belgium

Sponsor information

Leuven Institute for Fertility and Embryology [LIFE] (Belgium)
Hospital/treatment centre

Tiensevest 168
Leuven
3000
Belgium

Website	http://www.lifeleuven.be/
"ROR"	https://ror.org/012rp6f89

Funders

Funder type

Hospital/treatment centre

Leuven Institute for Fertility and Embryology [LIFE] (Belgium)

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

Editorial Notes

21/01/2019: Study stopped due to lack of funding
12/08/2016: Plain English summary added.