Pregnancy Clinical Trial
Official title:
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.
see above ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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