Clinical trial NCT00315029: Patient-Centered Implementation Trial for Single Embryo Transfer
Official title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Female Infertility
Pregnancy
Keywords: Implementation
Single embryo transfer
ICSI
IVF
prevention
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-04-17
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Female age \< 39 years
* In first cycle minimum of two embryos available for transfer

Exclusion Criteria:

* Medical necessity for single embryo transfer

Primary outcomes:
measure: Incidence choice for eSET
timeFrame: after embryo transfer
Secondary outcomes:
measure: Patient knowledge
timeFrame: during treatment
measure: patient decisional conflict
timeFrame: during treatment
measure: Patient experiences
timeFrame: duringg treatment
measure: Pregnancy outcomes
timeFrame: after treatment
measure: Cost-effectiveness
timeFrame: after follow up
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis Eindhoven
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
name: Rosella P Hermens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
name: Jan AM Kremer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
name: Didi D Braat, Prof. MD PhD
role: STUDY_CHAIR
affiliation: Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
name: Richard PT Grol, Prof. PhD
role: STUDY_CHAIR
affiliation: Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
name: Willianne Nelen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.