Does the test influence a couples decision to refrain from further treatment.
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the impact of the ReceptIVFity test on a couples decision prior to
treatment.
Secondary outcome
To determine clinical applicability of the test i.e. ease of sampling, the way
it might influence shared decision making, disadvantages vs advantages of the
test, psycho-social impact of the test.
Background summary
Research has shown that the species composition within the microbiome residing
in the urogenital tract is a proxy for survival of an early embryo and
successful implantation. Prior to an in vitro fertilization (IVF) or
intracytoplasmic sperm injection (IVF-ICSI) attempt, the ReceptIVFity test is
able to predict embryo implantation failure in women with an unfavourable
microbiome profile with a predictive accuracy of 93.3%.
Study objective
Does the test influence a couples decision to refrain from further treatment.
Study design
Randomised follow up trial.
Intervention
The ReceptIVFity test consists of collecting a vaginal swab and will be
analysed by the interspace profiling (IS-Pro) technique. The test result
consists of a personal microbiome profile linked to favourable/unfavourable
profile associated with embryo implantation failure.
Study burden and risks
The women who are randomized in the 'intervention group' will obtain a vaginal
swab by themselves. The test result of this vaginal swab will provide them
with insight in their personal vaginal microbiome profile. The predictive
accuracy of the test is 93.3%, i.e. women with an 'unfavourable profile' have
poor chance (6-7%) to conceive with an IVF/IVF-ICSI treatment. Knowledge about
their own microbiome profile can be beneficial, because the couple has the
choice to refrain from further treatment.
Participants will fill in a short questionnaire at 3 intervals for follow up.
This questionnaire (lastmeter) provides insight into the overall wellbeing of
the patient. The intervention group will also fill in an additional
questionnaire (invloedmeter). This questionnaire gives information about how
the test result influences the decision to continue or discontinue further
treatment.
In addition, a small subgroup (10-12 patients) of the intervention group will
be invited for qualitative research. This qualitative research consists of a
30-minute interview with a psychologist to investigate other aspects of the
ReceptIVFity test.
The burden en risk of participation may consist of a demotivating effect of an
unfavourable test result. Currently there are no therapeutic options available
to modulate an unfavorable profile in a favorable profile.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Indication for an IVF or IVF-ICSI procedure.
- 18 years < age < 44 years
- women before their first, second or third IVF/IVF-ICSI attempt
- willingness to provide a vaginal swab
- willingness to provide informed consent
Exclusion criteria
- Patients who do not speak the Dutch language
- a 4th IVF/IVF-ICSI attempt that is not part of standard care (not reimbursed by the insurer)
- Patients that will start with IVF/IVF-ICSI treatment within 2 weeks (they do not have time to take the results of the ReceptIVFity test into account when making the decision)
- Patients who had any hormone treatment in the last 2 months
- Patients with premature ovarian insufficiency (POI) or within an egg donation program
- Patients with severe psychological or physical complaints prior to the treatment (difficult to distinguish from the effects of IVF/IVF-ICSI treatment)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59726.078.16 |
| OMON | NL-OMON27025 |