With this follow up study we would like to find out how couples from both control- and interventiongroup look back on the decision they made regarding embryo transfer during the PITS study. Not much is known about the long term effects of using DA…
ID
Source
Brief title
Condition
- Other condition
- Family issues
Synonym
Health condition
voortplantingsgeneeskunde, IVF
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decisional Regret is the primary study parameter. We would like to determine to
what extent couples experience a feeling of regret when it comes to the
decision they made during the PITS study for SET (single embryo transfer) or
DET (double embryo transfer).
Secondary outcome
Quality of life, measured with the Mental Health Continuüm is the secundairy
study parameter.
The study also has some determinants, which are:
-Choice for SET or DET during the PITS study
-Outcome of treatment during PITS study (singleton or twin pregnancy, live or
still born)
-Self efficacy with the general Self Efficacy Scale
-Family situation (amount of children)
-Hopes and expectations before starting treatment
Background summary
Between November 2006 and July 2007 the so called PITS study was conducted
among 300 couples that were on the waiting list for IVF treatment. These
couples were about to receive treatment in IVF clinics in Nijmegen, Veldhoven,
Ede, Apeldoorn or Eindhoven. This PITS study focussed on a multifaceted
implementation strategy in IVF care, to help couples decide to either transfer
1 or 2 embryos during their treatment. An important part of this strategy was a
decision aid (DA) developed in Radboudumc Nijmegen. This DA explained all the
pros and cons and risks for the transfer of 1 and 2 embryos. The DA also
described the chances of pregnancy for single embryo transfer and double embryo
transfer.
Couples were divided into two groups, a controlgroup and an intervention group.
The controlgroup received regular IVF care and the interventiongroup received
regular IVF care plus the DA. Results of the PITS study showed that couples
from the interventiongroup were more likely to choose single embryo transfer
compaired to the controlgroup (11% difference). Another result from the PITS
study is that couples from the interventiongroup felt well informed and
therefore more empowered to make a decision for themselves.
Not much is known about the effects of decision aids on the long term, and with
this follow up study we hope to learn more about these long term effects of
decision aid use in IVF care (and possibly health care in general).
Study objective
With this follow up study we would like to find out how couples from both
control- and interventiongroup look back on the decision they made regarding
embryo transfer during the PITS study. Not much is known about the long term
effects of using DA's in healthcare, since previous research on DA's only
follow up after 1-3 years. By using a questionnaire with questions regarding
the patients' choice on embryo transfer during PITS study, their quality of
life and feelings of regret we will learn more about the patients' view on
their choice. This way we can learn more about the long term effects of the use
of this particular DA, but results from this study might also give more insight
on DA use in general healthcare, since there is no study known in literature
with a follow up time that is as long as it is in this study.
Study design
We will ask couples that participated in the PITS study and that had more than
1 embryo available for transfer to participate in this follow up study. We
will collect the correct adresses by performing a GBA-check in the Radboudumc
Nijmegen. If this will not give the result we hoped for we will use social
media (Facebook) to find the former PITS study participants by searching for
first and last names. We will create a special Facebook page of the PITS study,
from which we will contact the former PITS-study participants. This will occur
via private message and will therefore not be visible to others.
When we have obtained the correct home adresses, we will send these patients a
questionnaire, brochure for participants of scientific research, a consentform
and an explanation letter. The patients will be contacted from the hospital
they received treatment at the time of the PITS study. Patients can fill in the
consentform to let us known if they want to participate in this study or not,
and they can sent the consentform and questionnaire back to us.
The results of these questionnaires will be analyzed and internationally
reported.
Study burden and risks
Filling in the questionnaire and sending it back will only take 10-15 minutes
of the participants' time. Participants might have to go back in time since the
treatment we are reffering to happened over 8 years ago, but that will be the
only effort they have to put in in order to participate in our study. It is
possible that participants feel like filling in the questionnaire is heavy and
emotional, but we don't expect this to occur (since treatment is over 8 years
ago, it is not 'fresh' in memory). If we do get this negative feedback we will
report this and stop sending new reminders when we receive 10% negative
feedback (10% of the 222 invited participants, which means 22 negative
responses).
Geert Groteplein zuid 10
Nijmegen 6525 GA
NL
Geert Groteplein zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Couples that participated in the PITS studie (between November 2006 and July 2007) and that were undergoing IVF treatment where they had more then 1 embryo available for transfer. If couples participated in the entire PITS study (so we have a complete follow up) and they fit this criteria they can participate.
Exclusion criteria
Less then 2 embryo's available for transfer during PITS study, pregnant before the start of IVF, not a complete follow up
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 | NL53153.091.15 |