Patient-Centered Implementation Trial for Single Embryo Transfer
NCT ID: NCT00315029
Last Updated: 2008-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2006-11-30
2008-10-31
Brief Summary
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Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.
Study design: A randomised controlled trial
Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.
Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.
Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.
Secondary study parameters/outcome of the study:
* patient knowledge
* patient decisional conflict
* patient satisfaction
* IVF/ICSI treatment outcome.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Receives combined patient centred intervention
evidence based decision aid
evidence based decision aid
Possible reimbursement 4th IVF/ICSI cycle when necessary
Potential reimbursement 4th IVF/ICSI cycle when necessary
2
Standard treatment
No interventions assigned to this group
Interventions
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evidence based decision aid
evidence based decision aid
Possible reimbursement 4th IVF/ICSI cycle when necessary
Potential reimbursement 4th IVF/ICSI cycle when necessary
Eligibility Criteria
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Inclusion Criteria
* In first cycle minimum of two embryos available for transfer
Exclusion Criteria
18 Years
39 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Radboud Universty Nijmegen Medical Centre
Principal Investigators
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Rosella P Hermens, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Jan AM Kremer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
Didi D Braat, Prof. MD PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
Richard PT Grol, Prof. PhD
Role: STUDY_CHAIR
Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Willianne Nelen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
Locations
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Catharina ziekenhuis Eindhoven
Eindhoven, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
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References
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Pandian Z, Templeton A, Serour G, Bhattacharya S. Number of embryos for transfer after IVF and ICSI: a Cochrane review. Hum Reprod. 2005 Oct;20(10):2681-7. doi: 10.1093/humrep/dei153.
Lukassen HG, Braat DD, Wetzels AM, Zielhuis GA, Adang EM, Scheenjes E, Kremer JA. Two cycles with single embryo transfer versus one cycle with double embryo transfer: a randomized controlled trial. Hum Reprod. 2005 Mar;20(3):702-8. doi: 10.1093/humrep/deh672. Epub 2004 Dec 23.
Lukassen HG, Schonbeck Y, Adang EM, Braat DD, Zielhuis GA, Kremer JA. Cost analysis of singleton versus twin pregnancies after in vitro fertilization. Fertil Steril. 2004 May;81(5):1240-6. doi: 10.1016/j.fertnstert.2003.10.029.
Brabers AE, van Dijk L, Groenewegen PP, van Peperstraten AM, de Jong JD. Does a strategy to promote shared decision-making reduce medical practice variation in the choice of either single or double embryo transfer after in vitro fertilisation? A secondary analysis of a randomised controlled trial. BMJ Open. 2016 May 6;6(5):e010894. doi: 10.1136/bmjopen-2015-010894.
van Peperstraten A, Nelen W, Grol R, Zielhuis G, Adang E, Stalmeier P, Hermens R, Kremer J. The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial. BMJ. 2010 Sep 30;341:c2501. doi: 10.1136/bmj.c2501.
Other Identifiers
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ZonMw nr 945-16-105
Identifier Type: -
Identifier Source: secondary_id
PITS2006
Identifier Type: -
Identifier Source: org_study_id