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

Diagnostic test (ReceptIVFity) for recognition of embryo implantation failure in practice. - Implementation; impact ReceptIVFity test on the decision

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45617
Enrollment
303
Registered
2017-06-20
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subfertiliteit embryo implantation failure subfertility

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 f

Sponsors

Voortplantingsgeneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Indication for an IVF or IVF-ICSI procedure. - 18 years

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
To assess the impact of the ReceptIVFity test on a couples decision prior to treatment.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)