Patient-Centered Implementation Trial for Single Embryo Transfer

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.

Conditions

• Male Infertility
• Female Infertility
• Pregnancy

Interventions

BEHAVIORAL

evidence based decision aid

evidence based decision aid

BEHAVIORAL

Possible reimbursement 4th IVF/ICSI cycle when necessary

Potential reimbursement 4th IVF/ICSI cycle when necessary

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Rosella P Hermens, PhD · Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre

• Jan AM Kremer, MD, PhD · Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre

• Didi D Braat, Prof. MD PhD · Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre

• Richard PT Grol, Prof. PhD · Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre

• Willianne Nelen, MD, PhD · Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2008-09-30

Completion

2008-10-31

Countries

• Netherlands

Study Locations