Patient-Centered Implementation Trial for Single Embryo Transfer
Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Eindhoven, Netherlands
- Catharina Ziekenhuis Eindhoven
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Nijmegen, Netherlands, 6500HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female age < 39 years
- In first cycle minimum of two embryos available for transfer
Exclusion Criteria:
- Medical necessity for single embryo transfer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Receives combined patient centred intervention
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evidence based decision aid
Potential reimbursement 4th IVF/ICSI cycle when necessary
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No Intervention: 2
Standard treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Incidence choice for eSET
Time Frame: after embryo transfer
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after embryo transfer
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient knowledge
Time Frame: during treatment
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during treatment
|
|
patient decisional conflict
Time Frame: during treatment
|
during treatment
|
|
Patient experiences
Time Frame: duringg treatment
|
duringg treatment
|
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Pregnancy outcomes
Time Frame: after treatment
|
after treatment
|
|
Cost-effectiveness
Time Frame: after follow up
|
after follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rosella P Hermens, PhD, Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
- Principal Investigator: Jan AM Kremer, MD, PhD, Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
- Study Chair: Didi D Braat, Prof. MD PhD, Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
- Study Chair: Richard PT Grol, Prof. PhD, Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
- Principal Investigator: Willianne Nelen, MD, PhD, Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PITS2006
- ZonMw nr 945-16-105
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