search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Embryo selection by metabolomic profiling.


- candidate number3001
- NTR NumberNTR1178
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2008
- Secondary IDsincomplete VUmc
- Public TitleEmbryo selection by metabolomic profiling.
- Scientific TitleThe metabolomic profile of an embryo as selection criterium for embryo transfer in IVF or ICSI treatment: a randomised controlled clinical trial.
- ACRONYMN/A
- hypothesisHo: 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) studiedIn vitro fertilization (IVF), Metabolomic profile
- Inclusion criteriaPatients with SET, at least two embryos of equal quality.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-sep-2009
- Target number of participants370
- InterventionsOne group will get the conventional embryo selection (morphology) prior to transfer and one group gets in addition to the morphological selection metabolomic profiling.
- Primary outcomeLife birth rate.
- Secondary outcomeOngoing pregnancy rate. Ongoing pregnancy is defined as a positive fetal heart beat at 12 weeks gestational age.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. C.B. Lambalk
- CONTACT for SCIENTIFIC QUERIESDr. C.B. Lambalk
- Sponsor/Initiator VU University Medical Center, Department of Reproductive medicine
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications 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 summaryThe 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)
- RECORD10-jan-2008 - 27-jul-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl