|- candidate number||3001|
|- NTR Number||NTR1178|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jan-2008|
|- Secondary IDs||incomplete VUmc|
|- Public Title||Embryo selection by metabolomic profiling.|
|- Scientific Title||The metabolomic profile of an embryo as selection criterium for embryo transfer in IVF or ICSI treatment: a randomised controlled clinical trial.|
|- hypothesis||Ho: the life birth rate in patients after SET with only morphological embryo selection is equal to patients with metabolomic profiling added to morphological selection.
H1: the life birth rate in patients after SET with only morphological embryo selection is unequal to patients with metabolomic profiling added to morphological selection.
|- Healt Condition(s) or Problem(s) studied||In vitro fertilization (IVF), Metabolomic profile |
|- Inclusion criteria||Patients with SET, at least two embryos of equal quality.|
|- Exclusion criteria||1. Patients with DET (double embryo transfer);|
2. patients with less than 2 embryos of equal quality;
3. patients can only be included for one IVF/ICSI cycle.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2008|
|- planned closingdate||1-sep-2009|
|- Target number of participants||370|
|- Interventions||One group will get the conventional embryo selection (morphology) prior to transfer and one group gets in addition to the morphological selection metabolomic profiling.|
|- Primary outcome||Life birth rate. |
|- Secondary outcome||Ongoing pregnancy rate. Ongoing pregnancy is defined as a positive fetal heart beat at 12 weeks gestational age.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. C.B. Lambalk|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.B. Lambalk|
|- Sponsor/Initiator ||VU University Medical Center, Department of Reproductive medicine|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
Day 3 embryo selection by metabolomic profiling of culture medium with near-infrared spectroscopy as an adjunct to morphology: a randomized controlled trial.
Vergouw CG, Kieslinger DC, Kostelijk EH, Botros LL, Schats R, Hompes PG, Sakkas D, Lambalk CB.
Hum Reprod. 2012 Aug;27(8):2304-11. doi: 10.1093/humrep/des175. Epub 2012 May 30.
No evidence that embryo selection by near-infrared spectroscopy in addition to morphology is able to improve live birth rates: results from an individual patient data meta-analysis.
Vergouw CG, Heymans MW, Hardarson T, Sfontouris IA, Economou KA, Ahlström A, Rogberg L, Lainas TG, Sakkas D, Kieslinger DC, Kostelijk EH, Hompes PG, Schats R, Lambalk CB.
Hum Reprod. 2014 Mar;29(3):455-61. doi: 10.1093/humrep/det456. Epub 2014 Jan 8.
|- Brief summary||The high multiple pregnancy rate caused by IVF treatment leads to a higher incidence of medical, perinatal and neonatal complications and hence to higher health care costs. Single Embryo Transfer (SET) is an effective way to minimize risks of multiple pregnancies. Only one embryo is transferred, so the selection of the embryo with an optimum implantation potential very important. Currently, embryo selection is mainly based on morphological criteria using light microscope analysis. Because of its limited predictive value for ongoing pregnancy, new selection tools are being sought-after. Previous study showed that non-invasive metabolomic profiling seem to provide a strong addition to the selection of viable embryos and may serve as a useful methodology for rapid, non-invasive embryo selection. We hypothesize that pregnancy rates may improve when a more sensitive and specific selection tool like metabolomic profiling of biomarkers of oxidative metabolism by Near Infrared (NIR) Spectroscopy is used.
|- Main changes (audit trail)|
|- RECORD||10-jan-2008 - 27-jul-2015|