To compare two internationally widely used IVF culture media, the sequential culture medium G5 (G1.5 for culture on day 1-3 and G2.5 for day 4-6) from Vitrolife (Sweden) and a single step Continuous Single Culture Medium (CSCM) from Irvine (Ireland…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Live birth rate
Secondary outcome
Embryo development, implantation rate, clinical pregnancy rate, miscarriage
rate, ongoing pregnancy rate, multiple pregnancy rate, morphometric parameters
of foetal development at 8, 12 and 20 weeks of pregnancy, mean values of
maternal serum markers during first trimester screening, mean birth weight,
mean gestational age at birth and percentage of children with congenital
abnormalities.
Background summary
A variety of embryo culture media are currently used in human in vitro
fertilization procedures (IVF). Previous studies have indicated that
alterations in the composition of the culture media can affect embryo quality,
pregnancy rates and foetal growth. At the beginning of IVF a single culture
medium was used for all embryonic stages, while later on it was recognized that
the embryo has different needs during the early and late preimplantation
stages. This has led to the development of sequential culture media; two media
with different ingredients for different days of culture. These media were the
most widely used. Recently however, also with the introduction of time-lapse
imaging, the popularity of single step media is increasing again, but proper
studies comparing the outcomes of these media that differ in composition, are
missing.
Study objective
To compare two internationally widely used IVF culture media, the sequential
culture medium G5 (G1.5 for culture on day 1-3 and G2.5 for day 4-6) from
Vitrolife (Sweden) and a single step Continuous Single Culture Medium (CSCM)
from Irvine (Ireland), to find out which one leads to the best live birth rate
per patient and to investigate their effect on perinatal outcome of the
resulting children.
Study design
A multi-center, randomized, double-blinded comparison of G5 and CSCM for human
preimplantation embryo culture.
Intervention
The IVF treatment (clinical and laboratory procedures) will be performed as
usual in each clinic. Randomization will decide in which commercially available
culture medium (either G5 or CSCM) to culture all oocytes and resulting embryos
of each patient. Only the first cycle is included in this study. In second or
subsequent cycles the culture medium of choice in each IVF laboratory will be
used.
Study burden and risks
After providing written consent, there is little burden or benefit for the
participating women. These women follow normal routine IVF procedures, and, if
a pregnancy occurs, normal routine pregnancy evaluations. The only effort
consists of filling in a *pregnancy and delivery*-log after the pregnancy
screenings at around 8, 12 and 20 weeks of pregnancy and after delivery. Both
culture media are certified and used extensively both in the Netherlands and
abroad.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Inclusion criteria
All couples that present to one of the participating centres for an IVF/ICSI treatment.
Exclusion criteria
Patients undergoing a PGD cycle, patients undergoing a modified natural cycle, patients requiring gestational surrogacy and patients who participated in the study before will be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50712.000.14 |
| OMON | NL-OMON29477 |