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; 341 doi: https://doi.org/10.1136/bmj.c2501 (Published 30 September 2010) Cite this as: BMJ 2010;341:c2501
- Arno van Peperstraten, resident in obstetrics and gynaecology1,
- Willianne Nelen, senior research fellow1,
- Richard Grol, professor in quality of care2,
- Gerhard Zielhuis, professor of epidemiology3,
- Eddy Adang, senior lecturer in health economics3,
- Peep Stalmeier, senior research fellow34,
- Rosella Hermens, senior research fellow2,
- Jan Kremer, professor in reproductive medicine1
- 1Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, Netherlands
- 2Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre
- 3Department of Epidemiology, Biostatistics and HTA, Radboud University Nijmegen Medical Centre
- 4Department of Radiation Oncology, Radboud University Nijmegen Medical Centre
- Correspondence to: A M van Peperstraten A.vanpeperstraten{at}obgyn.umcn.nl
- Accepted 19 April 2010
Abstract
Objective To evaluate the effects of a multifaceted empowerment strategy on the actual use of single embryo transfer after in vitro fertilisation.
Design Randomised controlled trial.
Setting Five in vitro fertilisation clinics in the Netherlands.
Participants 308 couples (women aged <40) on the waiting list for a first in vitro fertilisation cycle.
Interventions The multifaceted strategy aimed to empower couples in deciding how many embryos should be transferred. The strategy consisted of a decision aid, support of a nurse specialising in in vitro fertilisation, and the offer of reimbursement by way of an extra treatment cycle. The control group received standard care for in vitro fertilisation.
Main outcome measures Use of single embryo transfer in the first and second treatment cycles as well as decision making variables and costs of the empowerment strategy.
Results After the first treatment cycle, single embryo transfer was used by 43% (65/152) of couples in the intervention group and 32% (50/156) in the control group (difference 11%, 95% confidence interval 0% to 22%; P=0.05). After the second treatment cycle, single embryo transfer was used by 26% (14/154) of couples in the intervention group compared with 16% (8/51) in the control group (difference 10%, −6% to 26%; P=0.20). Compared with couples receiving standard care, those receiving the empowerment strategy had significantly higher empowerment and knowledge levels but no differences in anxiety levels. Mean total savings per couple in the intervention group were calculated to be €169.75 (£146.77; $219.12).
Conclusions A multifaceted empowerment strategy encouraged use of single embryo transfer, increased patients’ knowledge, reduced costs, and had no effect on levels of anxiety or depression. This strategy could therefore be an important tool to reduce the twin pregnancy rate after in vitro fertilisation. This trial did not, however, demonstrate the anticipated 25% difference in use of single embryo transfer of the power calculation.
Trial registration ClinicalTrials.gov NCT00315029.
Footnotes
We thank the participating clinics who helped with inclusion of couples and Jose Terken and Annelies Pellegrino for the counselling sessions and distribution of the questionnaires.
Contributors: AP designed the trial, developed and managed the main database, interpreted the analysis, and drafted the paper. He is guarantor. WN designed the trial, analysed and interpreted the data, and drafted the paper. RG designed and implemented the trial and drafted the paper. GZ designed the trial, interpreted the data, and drafted the paper. EA designed the trial, interpreted the cost analysis data, and drafted the paper. PS designed the evaluation of decision making variables, interpreted the decision making outcomes, and drafted the paper. RH designed the study, analysed and interpreted the data, and drafted the paper. JK led the trial team, was principal investigator, and drafted the paper. All authors reviewed successive drafts of the paper.
Funding: This study was funded by the Netherlands Organisation for Health Research and Development (grant No 945-16-105). All researchers are independent from this source of funding. The study sponsor had no role in the study design, collection, analysis, and interpretation of data, the writing of the article, and the decision to submit it for publication.
Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; and (4) no non-financial interests that may be relevant to the submitted work.
Ethical approval: The study was approved by the regional ethics committee for medical research.
Data sharing: Dataset available from corresponding author at a.vanpeperstraten{at}obgyn.umcn.nl.
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