·implementation objective(s)/research question(s): The main aim is to compare the effectiveness and costs of the implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI),…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Subfertiliteit, Paren die IVF/ICSI behandeling zullen ondergaan
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
·outcome measures and process indicators: Main outcome measure is the eSET
occurrence rate and cost-effectiveness of the combined strategy.
Secondary outcome
Secondary outcome measures are in the field of: 1) patient knowledge 2) patient
decisional conflict 3) patient satisfaction and 4) IVF/ICSI treatment outcome.
Background summary
This trial will investigate the implementation of single embryo transfer
(eSET). Implementation of eSET can be done through different strategies. Many
of them have the disadvantage that patients lose the ability to choose
themselves. They lose their autonomy to make their medical decisions. The goal
of our study is to implement eSET with respect to the couple's autonomyto
participate in shared decision making. Prior to this study, focusgroup
interviews were held and the main conclusions were that the most important
inhibitting factors are with the patient-couples. They seem uninformed about
risks and complications of twin pregnancies and often have financial reasons to
transfer more embryos at once. The design of our trial is to see if counselling
with an evidence-based decision aid could raise the incidence for the choice
for eSET. Furthermore we will also investigate if reimbursement of a (possible)
4th cycle has an effect on that incidence. In our study design the 4th cycle
will be paid for if the couples have chosen for eSET in the first 2 cycles.
Study objective
·implementation objective(s)/research question(s): The main aim is to compare
the effectiveness and costs of the 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
design: A randomised controlled trial is performed.
Intervention
intervention to be implemented: eSET in IVF/ICSI
Study burden and risks
The burden for participants could consist of the possible 4th IVF/ICSI
treatment cyle. This is only applicable for couples who are not pregnant after
3 cycles and who have chosen SET in cycle 1 and 2.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Couples starting with their first IVF/ICSI cycle (with or without earlier successful treatment) with the female younger then 40 years.
Exclusion criteria
Medical nesessity for SET. Female older then 39 years. Less then 2 embryos available for transfer in the first cycle.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11293.091.06 |