Diagnostic test (ReceptIVFity) for recognition of embryo implantation failure in practice

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%.



Objective

Does the test influence a couples decision to refrain from further treatment.

Study design

Randomised follow up trial.

Study population

Women eligible for IVF or IVF-ICSI treatment who are willing to obtain a vaginal swab prior to treatment.

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.

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.

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

Secondary hypothesis:

2. Women with a favourable profile will tend to continue IVF/IVF-ICSI treatment in
comparison with the group of untested individuals

before, during and after treatment
The first assessment in the intervention group will be after being informed about their test
result.

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
test.

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.