Prospective value of the Genea natural killer cell activity (NKa) blood test and its extended panels on live birth rate in women under 40 years doing In vitro fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) or frozen embryo transfer cycles.

A prospective observational study investigating the association between Genea Natural Killer (NK) Cell Activity Test results and reproductive outcomes in patients undergoing assisted reproductive treatment.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12626000927325

Enrollment

Registered

2026-07-28

Start date

2026-07-21

Completion date

2028-07-21

Last updated

2026-08-03

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

Conditions

None listed

Brief summary

This is a prospective study to assess the diagnostic significance of an NKa result. Women will be recruited from clinics at Genea in NSW, ACT, QLD, VIC, SA and WA. They will have the NKa blood test and will agree that both their fertility specialist and themselves will be blinded to the result for their first embryo transfer following the test.

Interventions

Participants will undergo the Genea Natural Killer (NK) Cell Activity Test using a peripheral blood sample collected as part of fertility assessment. NK cell activity results will be recorded in our patient information system Baby Sentry and analysed in relation to participant characteristics and clinical outcomes. No experimental treatment or alteration to standard clinical care will occur as part of the study. Patients will be observed for a total duration of 2 years.

Eligibility

Sex/Gender

All

Age

No minimum to 40 Years

Healthy volunteers

Inclusion criteria

Women below 40 years. • Any fertility diagnosis requiring an embryo transfer within 6 months of the blood test • Consent to being blinded to the result for the first transfer and NOT taking any immune therapy (clexane, prednisolone, dexamethasone, intralipid, PRP, LIT, anti TNF) for the first transfer. • Undergoing IVF/ICSI for fresh transfer, or frozen embryo transfer. • Can include PGT cases. • The study is open to first time patients as well as those with previous failures or miscarriages.

Exclusion criteria

• Women aged >40 years. • Taking any immune therapy with 2 months of the test. • Taking any immune therapy for other systemic disease. • Unwilling to proceed with first embryo transfer without immune therapy. • Egg freezing only. - Patients must not already be pregnant

Outcome results