|- candidate number||27513|
|- NTR Number||NTR6620|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jul-2017|
|- Secondary IDs||NL59726.078.16 MEC-2016-692|
|- Public Title||Diagnostic test (ReceptIVFity) for recognition of embryo implantation failure in practice|
|- Scientific Title||Diagnostic test (ReceptIVFity) for recognition of embryo implantation failure in practice|
|- ACRONYM||Implementation; impact ReceptIVFity test on the decision|
|- hypothesis||Primary hypothesis: |
1. Women with an unfavourable profile will discontinue the IVF/IVF-ICSI treatment
earlier or more often than couples who were not tested
2. Women with a favourable profile will tend to continue IVF/IVF-ICSI treatment in
comparison with the group of untested individuals
|- Healt Condition(s) or Problem(s) studied||Microbiome, Vagina, Embryo implantation|
|- 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
- 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)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2017|
|- planned closingdate||1-aug-2018|
|- Target number of participants||303|
|- Interventions||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.|
|- Primary outcome||The primary endpoint is the difference in the number of couples that discontinue IVF or
IVF-ICSI treatment based on an unfavourable profile and those women who are not
tested (the control group).|
|- Secondary outcome||- The difference in proportion to refrain from further IVF/IVF-ICSI treatment between
the favourable outcome group and the control group.|
- The difference in proportion to refrain from further IVF/IVF-ICSI treatment between
the favourable outcome group and the unfavourable outcome group.
|- Timepoints||before, during and after treatment
The first assessment in the intervention group will be after being informed about their test
Control group: at intake (medication, logistics, treatment) for patient who will start an IVF
attempt for the first time, day of pick up new medication for patient who will start with a
second/third IVF/IVF-ICSI attempt.
The second assessment will be at the day of the oocyte retrieval.
The third assessment will be on the day the patients call with the result of the pregnancy
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Rivka Koedooder|
|- CONTACT for SCIENTIFIC QUERIES|| Rivka Koedooder|
|- Sponsor/Initiator ||ZonMw ‘Medische Inspiratorprijs 2016'|
(Source(s) of Monetary or Material Support)
|ZonMw ‘Medische Inspirator 2016'|
|- Brief summary||Background|
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%.
Does the test influence a couples decision to refrain from further treatment.
Randomised follow up trial.
Women eligible for IVF or IVF-ICSI treatment who are willing to obtain a vaginal swab prior to treatment.
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.
Primary study parameters/outcome of the study
To assess the impact of the ReceptIVFity test on a couples decision prior to treatment.
Secondary study parameters/outcome of the study
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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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 and risk of participation may consist of a demotivating effect of an unfavourable test result. Currently there are no therapeutic options available to modulate an unfavourable profile in a favourable profile.
|- Main changes (audit trail)|
|- RECORD||7-jul-2017 - 26-aug-2017|