Primary Objective: To identify dropout rates at all stages of fertility care at the fertility centres of Isala in Zwolle, Erasmus MC in Rotterdam, Reinier de Graaf group in Voorburg, Elisabeth Twee Steden in Tilburg, the St Antonius Ziekenhuis in…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
- Reproductive tract disorders NEC
- Family issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dropout rates during fertility work-up, non-IVF treatment or IVF/ICSI
Secondary outcome
Reasons for drop-out
Patient satisfaction with received care
Demographic and psychological characteristics of the couples
Predictors of discontinuation of treatment
Background summary
Due to major advances in artificial reproductive technology (ART) treatments
success rates, often presented as ongoing pregnancy rates or live birth rates,
are increasing. Nowadays, pregnancy rates after IVF are comparable with natural
conception rates per cycle. However, several studies have reported high dropout
rates, varying from 23% up to 60%, during fertility treatment and from a
clinicians point of view it can be stated that high dropout rates negatively
affect the clinics performance. Drop out is defined as leaving the program for
reasons other than pregnancy or heaving reached a point beyond which treatment
is not useful anymore. In case a couple does not return to the clinic within 6
months during treatment or work up is also defined as drop out.
Studies have revealed that emotional, economic and physical burden of a
fertility program can be a reason to drop out. These studies mostly involve
couples that underwent IVF, although a few studies reported on couples dropping
out on a waiting list for IVF and during fertility treatment in general.
Fourteen studies in the systematic review by Gameiro et al. published data on
predictors for drop out, mainly on sociodemograpic and fertility treatment
predictors. Only three studies published on psychosocial predictors such as
anxiety, depressive symptoms and marital and relational problems. No
significant predictors were found to explain patient drop out, however in two
third of the studies focussing on depression and ART an association was found.
The authors came to the conclusion that more research needs to be done to fully
understand drop out due to low power of the studies.
To be able to predict and eventually prevent drop out it is necessary to assess
thoroughly the existence of possible prognostic factors that might generate
drop out.
Study objective
Primary Objective:
To identify dropout rates at all stages of fertility care at the fertility
centres of Isala in Zwolle, Erasmus MC in Rotterdam, Reinier de Graaf group in
Voorburg, Elisabeth Twee Steden in Tilburg, the St Antonius Ziekenhuis in
Nieuwegein, Maxima Medisch centrum in Veldhoven and Noordwest Ziekenhuis groep
in Alkmaar/Den Helder.
.
Secondary Objective(s):
• To investigate the reasons for drop out
• To examine patient satisfaction with received fertility care
• To identify the demographic characteristics of drop out patients
• To identify predictors for discontinuation
Study design
Setting: This prospective multi centre cohort study will be performed at the
fertility centres of of Isala in Zwolle, Erasmus MC in Rotterdam, Reinier de
Graaf group in Voorburg, Elisabeth Twee Steden in Tilburg, St Antonius
Ziekenhuis te Nieuwegein, Maxima Medisch centrum te Veldhoven and Noordwest
Ziekenhuis groep in Alkmaar/Den Helder.
Every new eligible patient and her partner will both be asked for informed
consent to participate in this study at their first visit at the clinic during
the intake by the treating doctor. After inclusion the couple will receive an
e-mail link to a website based questionnaire which is entitled to the first
questionnaire (Q1). From the intake onwards every couple will have their
regular work up and/or treatment visits during which evaluation will take
place using consecutive another questionnaire (Q2, Q3 or Q4). The first
questionnaire will focus on psychological and socio-demographic questions,
whereas the other questionnaires will address coping styles, depression and
anxiety.
When pregnancy is achieved, patients are invited to fill in Q6, to evaluate the
provided care. When treatment is stopped on medical advice, those patients are
excluded from any further follow up. Other patients are followed up as drop out
after they have not showed up to the clinic for at least six months. Those
patients are contacted to fill in the final questionnaire (Q5). This
questionnaire will apart from FertiQol, SCREENIVF and MMQ also assess PCQ
infertility as well as reasons of withdrawal.
Study burden and risks
No additional risks are expected. The only burden for the patients is that it
will cost some extra of their time to fill in the questionnaire.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
• Female age between 18 and 44 years
• Couples with any type of subfertility referred to one of the 5 participating centres
• Both partners are willing and able to separately fill out the questionairres
Exclusion criteria
• Unable to read or speak the Dutch language
• Medical contra-indication for pregnancy
• Previous OFO, non IVF or IVF/ICSI cycles
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 |
---|---|
ClinicalTrials.gov | NCT02302781 |
CCMO | NL47393.075.14 |