C.R.E.A.T.E.-PREP™ Chronobiological Reproductive Endocrine Assessment & Targeted Entrainment — Pre-Analytical Patient Preparation Protocol for Standardized Laboratory Sampling in Personalized Reproductive Medicine
Year: 2026
Type: report
Abstract: Pre-analytical variability accounts for 46–68 % of total diagnostic error in laboratory medicine, yet reproductive endocrinology lacks a standardized, pathophysiology-based patient preparation protocol. Existing guidelines ignore chronobiological desynchronization of the HPA-HPG axes and fail to address the emerging entity of AI-induced psycho-hormonal stress, which demonstrably alters cortisol pulsatility and GnRH frequency before the sample is ever drawn.Objective: To develop C.R.E.A.T.E.-PREP™, the first integrative pre-analytical protocol that synchronizes patient preparation with (i) individual cycle chronotype phenotyping (C.R.E.A.T.E.-RTM framework), and (ii) AI-Interaction Fertility Index (AIFI) screening for digital stress-mediated HPA activation.Methods: The protocol was constructed by cross-mapping the 7-axis diagnostic matrix of C.R.E.A.T.E.-RTM and the validated AIFI cortisol/AMH correlation model (n=682) onto pre-analytical variable taxonomy. Six evidence-based preparation modules were defined: (1) Chronobiological Alignment, (2) AI-Detox & Digital Hygiene, (3) Metabolic-Nutritional Standardization, (4) Psychosomatic Stabilization, (5) Medication-Supplement Review, and (6) Cycle-Specific & Assay-Specific Instructions. Standard Operating Procedures (SOPs) were calibrated for hormonal panels, AMH, cortisol, genetic panels, and microbiome sampling.Results: The protocol introduces chronotype-adjusted sampling windows (e.g., cortisol draw at 07:30–08:00 for circadian-type vs. 09:00–09:30 for delayed sleep-phase), mandatory 48-hour AI-Detox before HPA-sensitive assays for patients with AIFI ≥ 51, and a unified clinician-laboratory checklist that reduces pre-analytical rejection rates. The framework is designed to feed directly into the C.R.E.A.T.E.-RTM 7-axis phenotyping algorithm and the AI-Induced Infertility clinical pathway.Conclusion: C.R.E.A.T.E.-PREP represents a paradigm shift from generic 'fasting instructions' to pathophysiology-guided, phenotype-specific pre-analytical standardization. Integration of chronobiology and AI-stress screening into laboratory preparation is proposed as a new quality standard in personalized reproductive medicine.
Author: Hudziak, Viktoriya
Language: English
Subfield: Medical Laboratory Technology
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7204161276