Condition category
Urological and Genital Diseases
Date applied
20/02/2012
Date assigned
27/03/2012
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Stephan Gordts

ORCID ID

Contact details

Leuven Institute for Fertility and Embryology
Tiensevest 168
Leuven
3000
Belgium

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 measures

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

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

http://www.lifeleuven.be/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/08/2016: Plain English summary added.