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The efficacy of the embryo transfer catheter in IVF and ICSI is operator-dependent: a randomized clinical trial


- candidate number4133
- NTR NumberNTR1463
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2008
- Secondary IDsClinicaltrials.gov number is NCT00766714 Ethisch comité is UZGhent 00.002
- Public TitleThe efficacy of the embryo transfer catheter in IVF and ICSI is operator-dependent: a randomized clinical trial
- Scientific TitleThe efficacy of the embryo transfer catheter in IVF and ICSI is operator-dependent: a randomized clinical trial
- ACRONYMIVF catheter study
- hypothesisThere are no differences in pregnancy rates in IVF between two different types of transfercatheter
- Healt Condition(s) or Problem(s) studiedFertility problems, In vitro fertilization (IVF), Intracytoplasmic sperm injection (ICSI)
- Inclusion criteria1. Patients undergoing embryo transfer in our IVF program between 2000 and 2005.
- Exclusion criteria1. Patients not giving consent were excluded.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1999
- planned closingdate31-dec-2005
- Target number of participants1412
- InterventionsA prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5 was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program immediately prior to embryo transfer.
- Primary outcomeClinical pregnancy rates
- Secondary outcomeRates of difficult transfer and of catheter failure
- TimepointsTrial closed january 2006
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. dr. Petra Sutter, de
- CONTACT for SCIENTIFIC QUERIESProf. dr. Petra Sutter, de
- Sponsor/Initiator University Ghent
- Funding
(Source(s) of Monetary or Material Support)
University Ghent
- PublicationsN/A
- Brief summaryIn conclusion we have found that variation in pregnancy rates between embryo transfer catheters depends on the variation between operators. Although the present randomized prospective study did not detect a significant difference in overall success rate between the Cook and Frydman catheter, when correcting for the effect of operator by employing interaction terms between catheter and operator, a subgroup analysis revealed that our study involved three different types of operators: the first worked equally well with Cook and Frydman, the second worked better with Cook, and the third with Frydman. This effect was regardless of the absence of significant differences in total success rate among the three operators collapsing over the two types of catheter.
- Main changes (audit trail)
- RECORD27-sep-2008 - 14-okt-2008


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