Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000927325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/06/2026
Date registered
Help: Date registered
28/07/2026
Date last updated
Help: Date last updated
28/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Additional trial identifiers [1] 317899 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Pregnancy rate 342506 0
Condition category
Condition code
Reproductive Health and Childbirth 338633 338633 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of the intervention or exposure
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.
Intervention code [1] 334518 0
Diagnosis / Prognosis
Description of the comparator or control
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345905 0
Pregnancy rate following first blinded embryo transfer
Timepoint [1] 345905 0
Post embryo transfer and up to 2 years post blood collection
Secondary outcome [1] 463718 0
Number of embryo transfers before a successful live birth
Timepoint [1] 463718 0
Up to 2 years post blood test
Secondary outcome [2] 463720 0
The uptake and use of immune therapy, this will be assessed as a composite outcome.
Timepoint [2] 463720 0
Up to 2 years post blood test.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
40 Years
Sex
Females
Healthy volunteers
No
Key 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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A total of 600–1,200 participants will be recruited, with an interim analysis after 600 participants. The study is powered at 80% with a 95% confidence level. Live birth rates will be compared between groups, with recruitment extended to 1,200 participants if the interim analysis indicates additional participants are required to detect the expected effect.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/07/2026
Date of last participant enrolment
Anticipated
21/07/2028
Actual
Date of last data collection
Anticipated
21/07/2030
Actual
Sample size
Target
1200
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 29701 0
Genea Day Surgery - Sydney
Recruitment hospital [2] 29702 0
Genea Canberra - Deakin
Recruitment hospital [3] 29703 0
Genea Northwest - Bella Vista
Recruitment postcode(s) [1] 46049 0
2000 - Sydney
Recruitment postcode(s) [2] 46050 0
2600 - Deakin
Recruitment postcode(s) [3] 46051 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 322229 0
Other
Name [1] 322229 0
Genea Fertility
Country [1] 322229 0
Australia
Primary sponsor type
Individual
Name
Professor Gavin Sacks - Flow fertility with Genea
Address
Country
Australia
Secondary sponsor category [1] 325363 0
Individual
Name [1] 325363 0
Nicole Mcpherson - Genea Fertility SA
Address [1] 325363 0
Country [1] 325363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320752 0
Genea Ethics Committee
Ethics committee address [1] 320752 0
Ethics committee country [1] 320752 0
Australia
Date submitted for ethics approval [1] 320752 0
10/02/2026
Approval date [1] 320752 0
10/03/2026
Ethics approval number [1] 320752 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151502 0
Prof Gavin Sacks
Address 151502 0
Flow fertility with Genea, Suite 1905, Level 19 Westfield Tower 2/101 Grafton St, Bondi Junction NSW 2022
Country 151502 0
Australia
Phone 151502 0
+61416350744
Fax 151502 0
Email 151502 0
[email protected]
Contact person for public queries
Name 151503 0
Gavin Sacks
Address 151503 0
Flow fertility with Genea, Suite 1905, Level 19 Westfield Tower 2/101 Grafton St, Bondi Junction NSW 2022
Country 151503 0
Australia
Phone 151503 0
+61416350744
Fax 151503 0
Email 151503 0
[email protected]
Contact person for scientific queries
Name 151504 0
Dean Morbeck
Address 151504 0
Genea, Level 3/321 Kent St, Sydney NSW 2000
Country 151504 0
Australia
Phone 151504 0
+61 1300 361 795
Fax 151504 0
Email 151504 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.