Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03445923 |
| Other study ID # |
954-17 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2018 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Fertilitetscentrum AB |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
All patients starting an IVF-treatment at the clinics, and meeting the inclusion criteria,
will be offered to participate in the study. Randomization will be performed on day 5 and the
patients will be allocated into either morphology only group or time-lapse group. Embryos
will be cultured to day five according to the clinics own routines. All embryos in both
groups will be cultured using time-lapse incubation. In the control group the embryo
selection will be based only on traditional morphological evaluation and in the treatment
group a time-lapse selection model (KID Score day 5) will be used to select the embryo.
Description:
The aim is to study if algorithm calculated from time-lapse photography of human embryos per
se can enhance the prediction of the embryo´s reproductive potential compared to embryo
morphology alone.
METHODS AND MATERIAL IVF procedure Oocytes retrieved 36±1h after hCG administration will be
fertilized by either standard insemination or ICSI. The morning after oocyte retrieval (day
1) zygotes will be placed into embryo time-lapse slides for culture up to the day of transfer
(day 5). During the culture time, embryos will be kept in commercially available culture
media and will not be removed from the time-lapse incubator until day of transfer. Embryos
interact with the media and will be allowed to develop the blastocyst stage (5-6 days
culture) at which time selection for transfer will be made. During the in vitro culture a
single image captured in the time-lapse incubator will be used to routinely morphologically
grade embryos, according to the Istanbul consensus. On day 5, developing embryos will be
assessed (according to study vs. control group criteria) to select the embryo for transfer
into the patient. Supernumerous GQE will be cryopreserved for future use.
Time-lapse photography All embryos will be placed in wells of time-lapse culture dishes
(Embryoscope) according to the instructions of the manufacturer. Embryos in both groups will
be cultured to the blastocyst stage without any media change. The time-lapse system is
comprised of a desktop incubator that controls it´s environment (pH, CO2 and O2) as well as
taking pictures in up to 11 focal planes for the whole duration of the culture periods.
Morphological scoring Embryo morphology will be scored according to the Gardner score and
then translated to the Istanbul consensus system if needed for publication.
To assure that all embryologists annotate the embryo development correctly as well as score
the blastocysts in the same way, a validation process will be performed before the onset of
the study. The standardization will be accomplished through a process where the embryologists
will score 20 blastocysts at day 5-development stage, which will be provided on a CD,
imitating the procedure will be performed routinely in the laboratory. The embryologists will
have to be approved in order to be allowed to score embryos in the study.
Embryo evaluation (both groups). Embryos will be cultured in the Embryoscope time-lapse
system until day 5. If two or more blastocyst of good quality (GQB), i.e. fulfilling a
minimum morphological criteria of 3BB or better, develop, a preliminary decision is made on
which embryo to select for transfer. Thereafter the couple is randomized into either the
control or the time-lapse group.
Decision making in the time-lapse group If the couple is randomized into the time-lapse group
all embryos that have reached the blastocyst stage will be annotated. The blastocyst with the
highest KID (day 5) score will be chosen for transfer. To ensure a reliable KID scores can be
attained the morphological events; time to 2, 3, 4, and 5 cells, time to start of
blastulation (tSB), and TE scores must be evaluated.
Decision making in the control group If the couple are randomized to the control group, the
preliminary embryo selection decision will be maintained.
Study monitoring. A Data Study Monitoring Board (DSMB) Group will be assigned and have the
task of conducting both safety checks and an interim analysis (planned when ca 50% of the
patients have been recruited).
