Does embryo selection using time-lapse monitoring (TLM) with Eeva (Early Embryo Viability Assessment) improve the (cumulative) ongoing pregnancy rate after IVF & ICSI treatments?
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Onvruchtbaarheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the ongoing pregnancy rate of the fresh SET and
the cumulative ongoing pregnancy rate including the fresh SET and all
subsequent cryo transfers from the same ovum pick up cycle within one year.
Secondary outcome
Biochemical pregnancy rate and live birth rate after fresh SET, cumulative live
birth rate, miscarriage rate, time to pregnancy, embryo morphology and number
of usable embryos (ie embryos used for transfer or cryopreservation),
morphokinetic parameters, pregnancy rates in three female age groups,
cost-efficiency.
Background summary
Time-lapse monitoring (TLM) of embryo development has the potential to increase
the success rate of medically assisted reproduction (MAR) through more stable
culture conditions and/or optimized embryo selection procedures. Before
clinical introduction in Dutch IVF centers can be recommended, it is essential
to study whether TLM does indeed improve success rates and if so, whether this
increase is mediated by the improved culture conditions and/or optimized embryo
selection procedures.
We hypothesize that TLM will lead to a higher succes rate, thereby balancing
additional costs of time-lapse equipment.
Study objective
Does embryo selection using time-lapse monitoring (TLM) with Eeva (Early Embryo
Viability Assessment) improve the (cumulative) ongoing pregnancy rate after IVF
& ICSI treatments?
Study design
Multicenter, three-armed, randomized, controlled, double blind trial.
Intervention
A. Embryo selection based on Eeva TLM algorithm and continuous embryo culture
(TLM complete)
B. Routine embryo selection based on morphology and continuous embryo culture
(TLM culture only)
C. Routine embryo selection based on morphology and standard embryo culture and
embryo assessments outside the incubator (control)
Study burden and risks
The risks related to this study are comparable to the risks of a conventional
IVF treatment. Since it is unlikely that patients will be negatively affected
by this study we would like to ask clearance of contracting an insurance for
patients.
Amstelveenseweg 601
Amsterdam 1081 JC
NL
Amstelveenseweg 601
Amsterdam 1081 JC
NL
Listed location countries
Inclusion criteria
1st, 2nd or 3rd IVF or ICSI cycle
Single embryo transfer (SET)
Exclusion criteria
Double embryo transfer (DET)
Planned 'freeze all' cycle without a fresh embryo transfer
Participation in an interfering study
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55996.000.16 |