No registrations found.
ID
Source
Brief title
Health condition
Subfertility
Sponsors and support
Co-financing: Merck Serono
Intervention
Outcome measures
Primary outcome
The main study parameters are the ongoing pregnancy rate of the first fresh
SET and the cumulative ongoing pregnancy rate including the first fresh SET
and all subsequent cryo transfers from the same ovum pick up cycle within
one year.
Secondary outcome
The following secondary and exploratory endpoints will be analyzed:
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, outcome of manual time-lapse
annotations.
Background summary
The SelecTIMO study is a multicenter, three-armed, randomized, controlled,
double blind trial. It will establish whether the use of time-lapse monitoring
for embryo culture and embryo selection can outperform routine
morphological embryo culture and selection. Furthermore, this trial will reveal
whether an improvement of the clinical outcome is mediated through the
stable culture environment and/or optimized selection method using Eeva
time-lapse Results.
Study objective
Embryo selection using the Geri+ time-lapse system in combination with the
Eeva Test (Early Embryo Viability Assessment) will increase the (cumulative)
ongoing pregnancy rate of IVF and ICSI patients and thereby balance
additional costs of TLM (time-lapse monitoring) equipment.
Study design
N/A
Intervention
A) Embryo selection based on Eeva Results and continuous culture in Geri+
incubator (Geri+Eeva complete) and B) Routine embryo selection based on
morphology and continuous culture in Geri+ incubator (Geri culture only) will
be compared to C) Routine embryo selection based on morphology and
interrupted culture in Geri+ incubator (Control). Embryos in all three groups
will be cultured in the Geri+ time-lapse incubator.
D.C. Kieslinger
Amsterdam 1081 JC
The Netherlands
+31 (0)20 4442935
d.kieslinger@vumc.nl
D.C. Kieslinger
Amsterdam 1081 JC
The Netherlands
+31 (0)20 4442935
d.kieslinger@vumc.nl
Inclusion criteria
Women scheduled for a single embryo transfer (SET) during their first IVF or ICSI cycle at any of the participating IVF centers will be considered for inclusion.
Exclusion criteria
Patients with a double embryo transfer, a planned ‘freeze all’ cycle without a fresh embryo transfer, or participation in an interfering scientific study will not be included in the study. Patients who are treated with donor sperm or
donor oocytes will be excluded. Also patients scheduled for PGD or thawing of
oocytes after vitrification will be excluded.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL5314 |
| NTR-old | NTR5423 |
| Other | CCMO : 843001602 |