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

• Conditions: subfertiliteit; embryo implantation failure; subfertility; 10010273

• Registration Number: NL-OMON45617
• Lead Sponsor: Voortplantingsgeneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 303

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the impact of the ReceptIVFity test on a couples decision prior to<br /><br>treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine clinical applicability of the test i.e. ease of sampling, the way<br /><br>it might influence shared decision making, disadvantages vs advantages of the<br /><br>test, psycho-social impact of the test. </p><br>