To compare two widely used IVF culture media (G5 and HTF) to find out which one leads to the best live birth rate per patient.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure will be the percentage of live births after one year of
treatment.
Secondary outcome
Secondary outcome measures will be embryo quality, clinical pregnancy rate,
miscarriage rate, ongoing pregnancy rate, time to pregnancy, average birth
weight and percentage of children with congenital abnormalities.
Background summary
A variety of culture media for human preimplantation embryos are currently
used in human in vitro fertilization procedures (IVF). Previous studies have
indicated that alterations in the composition of the culture media could affect
embryo quality and pregnancy rates. Despite the importance of culture media, it
is not known what is the best medium to use for human in vitro fertilization
procedures.
Study objective
To compare two widely used IVF culture media (G5 and HTF) to find out which one
leads to the best live birth rate per patient.
Study design
A multi-center, randomized, double-blinded comparison of G5 and HTF for human
preimplantation embryo culture.
Intervention
Ovarian hyperstimulation and oocyte retrieval will be performed using standard
procedures. In the experimental arm, all oocytes and resulting embryos will be
cultured in G5-medium in all treatments for the duration of one year after
randomisation and in the control arm, oocytes and resulting embryos will be
cultured in HTF-medium in all treatments for the duration of one year after
randomisation. Embryo selection and transfer will subsequently be performed
using standard procedures.
Study burden and risks
After providing written consent, there is no involvement, burden or benefit for
the participating women. These women follow normal routine IVF procedures. The
only difference between both arms of the study is the culture medium used. Both
media are certified and have been used extensively both in the Netherlands and
abroad without any complications.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All couples that present to one of the participating centers for their first, or first after a successful pregnancy, IVF/ICSI treatment.
Exclusion criteria
Couples undergoing a PGD cycle, couples for which IVF is used to prevent the transmission of HIV and couples undergoing a modified natural cycle will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30441.000.09 |
| Other | NTR1979 (Dutch Trialregister ID) |