The primary objective of our proposal is to determine embryo development of donated human preimplantation embryos in four different culture media: (1) standard culture medium (control group), (2) culture medium with a uterine-like pH, (3) culture…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the blastocyst formation rate.
Secondary outcome
Secondary outcomes are embryo quality based on morphological assessment and
cell count, embryo metabolism, embryo gene expression, and embryo methylation
pattern.
Background summary
IVF has revolutionized reproductive medicine. Currently around 2 million IVF
treatments are provided worldwide each year. However, live birth is achieved in
only about one third of all treatments started. Therefore, there is a strong
incentive to improve IVF efficacy, and one of the main targets is to optimize
human embryo culture conditions as it is well known that better embryo culture
results in better quality embryos and subsequently higher pregnancy rates after
IVF.
One of the most important components of embryo culture is the embryo culture
medium being used. There are several embryo culture media for human IVF that
are commercially available nowadays. The choice of embryo culture medium
affects the pregnancy rate after IVF, as well as child outcomes, such as the
birth weight of children born. Even after 40 year of IVF, it remains unclear
which medium is best for human embryo culture. One of the reasons is that
research on the human in vivo environment of preimplantation embryos is very
limited, due to the difficulty of such measurements.
Our group has now measured physiological conditions (temperature and pH) in the
human uterus and analyzed uterine fluid samples on the presence and
concentration of 37 components during the *implantation window*, i.e. the time
during a menstrual cycle a preimplantation embryo would normally implant. Until
now such measurements have never been performed in such detail. From these
results we concluded that, by using currently available embryo culture media,
the in vitro environment of pre-implantation embryos in IVF laboratories
worldwide actually differs from the natural in vivo environment in the human
uterus. Based on these measurement we constructed a new embryo culture medium
that should mimic the in vivo conditions better than the culture media that are
currently being used. We hypothesize that this will result in improved IVF
efficacy.
We would like to test this by culturing donated left-over IVF embryos in a
culture medium currently being used for human IVF (control group) and compare
this with our new medium with a different pH and different composition based on
the human in vivo uterine conditions. To be able to discriminate between the
effect of the different pH and different medium composition we also constructed
two *intermediate culture media*, one where we only changed the pH, and one
where we only changed the composition compared to the control medium.
If successful, that is if we find similar or improved in vitro embryo
development with our new embryo culture medium, we will proceed with a clinical
pilot study, but this pilot study is beyond the scope of the current
application.
Study objective
The primary objective of our proposal is to determine embryo development of
donated human preimplantation embryos in four different culture media: (1)
standard culture medium (control group), (2) culture medium with a uterine-like
pH, (3) culture medium with a uterine-like composition, (4) culture medium with
a uterine-like pH and composition.
Study design
Randomization of thawed human preimplantation embryos that were donated for
research after IVF on day 3 or 4 of development to one of the following four
groups: (1) standard culture medium (control group, pH 7.3±0.1), (2) culture
medium with a uterine-like pH (pH 6.8±0.1), (3) culture medium with a
uterine-like composition, (4) culture medium with a uterine-like pH and
composition. There will be stratification for maternal age, embryo quality and
IVF center of origin during randomization.
Study burden and risks
Only left-over donated preimplantation embryos will be used for this study. The
couples that donated these embryos have already finished their IVF treatment
and have given written consent for the use of their left-over cryopreserved
embryos for research purposes when embryo storage for IVF purposes was
terminated. No incidental findings are expected from the proposed research. No
additional involvement is required for the couples and therefore there is no
burden, risk or benefit associated with this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Inclusion criteria
Vital thawed human left-over preimplantation embryos, consisting of a minimum
of 5 blastomeres that comprise >=50% of the whole embryo, that were donated for
research.
Exclusion criteria
Of all human left-over day 3 or 4 embryos that were donated for research:
embryos that did not survive the freeze-thawing procedure or embryos that
consist of less than 5 blastomeres and/or are less than 50% vital.
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 | NL72270.000.19 |