Clinical & operational evidence

The clinical foundation of intravaginal culture.

Decades of published intravaginal-culture evidence, and the validation pathway for EVEA™. Every clinical figure here is drawn from predicate IVC literature — not presented as EVEA's own result.

Two distinct sources of evidence.

1 · EVEA™ operational model
Operational impact — Eve's own modelling.

Figures below reflect Eve's operational model for EVEA™ deployment. They describe expected infrastructure and workload impact, not clinical outcomes.

Operational impactConventional IVFEVEA™Δ
Embryologist hands-on time per cycleBaseline~50–60% lower↓↓
Monitoring visits per cycleMultipleFewer
Dedicated cleanroom requiredYesNo
Embryologist-time reduction is an Eve operational estimate, derived from the conventional-IVF embryology steps that in-vivo culture removes — daily embryo assessment, media changes and incubator handling. Reduced monitoring-visit burden is consistent with published intravaginal-culture practice. Embryology staffing scales with hands-on laboratory workload per ASRM laboratory staffing guidance (Fertility and Sterility). Figures describe infrastructure and workload impact only, not clinical results.

2 · Predicate IVC literature
Clinical evidence — published IVC studies, not EVEA™.

The figures below are drawn from published intravaginal-culture literature for the general IVC methodology. They are a category baseline for the approach and are not EVEA™-specific results. EVEA™'s own clinical data will follow from a planned clinical evaluation.

Clinical finding (predicate IVC)FindingBasis
Clinical pregnancy rate~50%Randomised & cohort IVC studies, indicated patients
Safety & tolerabilityWell-toleratedPublished IVC reviews
Source: peer-reviewed intravaginal-culture literature (randomised, cohort and review studies). These are predicate-methodology findings for the IVC approach — independent of and distinct from EVEA™; they do not constitute clinical trial data for the EVEA™ platform.
Patient experience — published IVC study
Patient-reported measureResult
Reported no discomfort or pain on removal, and no negative impact on daily life100%
Said treatment met expectations and would recommend it to a friend78.3%
Source: published intravaginal-culture patient-experience study (university hospital, Malaysia). Predicate-methodology findings for the IVC approach — not EVEA™-specific results.

A peer-reviewed sibling-oocyte study.

A sibling-oocyte study comparing intravaginal culture with conventional IVF at a Malaysian teaching hospital reported fertilisation rates comparable to conventional IVF, with higher blastulation rates for the same oocyte cohort. The study was co-authored by Eve Co-Founder Col. Dr. Othman Sukhilmi.

Clinical Modality Validation: The evidence presented herein highlights the documented efficacy of the overarching intravaginal culture (IVC) methodology, drawing from published historical studies including the 2021 study by Dr. Othman Sukhilmi. This literature serves as a category baseline to validate the biological viability of the approach. It is independent of, and distinct from, Eve Fertility's proprietary product pipeline, and does not constitute clinical trial data for the EVEA™ platform.

Mohsin WSY, Abdullah Chue NS, Abdul Hamid F, Abu MA, Othman S, Mat Jin N, Woon SY, Abdul Karim AK, Ahmad MF. Published 2021. Full citation available on request.

Who IVC is indicated for.

The published evidence supports IVC for good-prognosis patients: unexplained infertility, mild male factor and adequate ovarian reserve. For complex cases — severe male factor, poor ovarian reserve, or where genetic testing is required — conventional IVF remains the appropriate pathway. IVC expands the funnel; it does not replace the backstop.

Device-specific data, forthcoming.

EVEA™-specific clinical data will follow from a planned clinical evaluation. The figures shown here reflect predicate IVC literature for clinical findings, and Eve's operational model for infrastructure and workload — not EVEA™ results. This distinction is deliberate and maintained throughout our materials.

Clinical dossier

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Full citations, study detail and the EVEA™ validation-trial plan are available to regulators, medical directors and clinical investors on request.

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