CLINICAL PROTOCOL MANAGEMENT OF BIOCHEMICAL PREGNANCY AND EVIDENCE-BASED APPROACH TO PLANNING THE NEXT PREGNANCY with Integration of the RPS-SCORE™ Assessment System and Master Lock™ Know-How

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Biochemical pregnancy (BP; Chemical Pregnancy, CP) is defined as a serum β-hCG elevation >5IU/L without ultrasound confirmation of a gestational sac. It represents the earliest clinicalphenotype of pregnancy loss, occurring before 5 weeks of amenorrhea, and frequently remainsundiagnosed in spontaneous conception cycles.In the context of assisted reproductive technologies (ART), biochemical pregnancy acquiresparticular prognostic significance. Studies demonstrate that after biochemical pregnancy, theoutcomes of subsequent clinical pregnancies differ substantially from patients with a negativepregnancy test: the clinical pregnancy rate in the next cycle reaches 37.3–38.4% versus 27.3% in thenegative β-hCG group (Bates et al., modified). The cumulative pregnancy rate after the first ARTattempt in patients with a previous biochemical pregnancy reaches 54.1%, exceeding thenegative-test group (46.5%).However, biochemical pregnancy after euploid embryo transfer (PGT-A) is an especially alarmingmarker. Current data indicate that in such cases BP reflects deep endometrial or immunologicaldysfunctions not detected by standard morphometric assessment (endometrial thickness, estradiollevels). This supports the hypothesis that BP after PGT-A is not a random event but signalspathology of the implantation window and/or maternal-placental immune dialogue.Competitive Positioning. Existing clinical protocols (ESHRE, ASRM, RCOG) treat biochemicalpregnancy primarily as a statistical category of pregnancy loss without a differentiated therapeuticalgorithm. The Hudziak Fertility Management Center proposes a fundamentally new approach —integration of BP into the Reproductive Pause Syndrome (RPS) assessment system using thepatented RPS-SCORE™ instrument and Master Lock™ know-how, ensuring personalized riskstratification and individualized therapy. To develop a personalized clinical protocol for biochemical pregnancy (BP) managementintegrating the Reproductive Pause Syndrome (RPS) concept and the RPS-SCORE™ multifactorialassessment system, ensuring an evidence-based approach to next pregnancy planning with minimizedrecurrence risk.Methods: The protocol is based on synthesis of evidence-based medicine (EBM) levels I–III, cohort studiesusing PGT-A, immunological screening, endometrial microbiome diagnostics, and psychosomaticassessment. The Master Lock™ know-how — a six-level intellectual property protection system — isintegrated, including the unique RPS-SCORE™ algorithm for patient stratification by BP recurrence risk.Results: A differentiated BP diagnostic algorithm with four clinical phenotypes is proposed (isolated BP,recurrent BP, BP in RPL context, BP after euploid embryo transfer). A staged endometrial rehabilitationprogram Endo-Restore 360™ and preconception preparation protocol PreConception Shield™individualized via RPS-SCORE™ are developed. It is demonstrated that biochemical pregnancy aftereuploid embryo transfer is not a random event but a marker of deep endometrial or immunologicaldysfunctions invisible under standard morphometric assessment.Conclusions: Biochemical pregnancy should be regarded as a significant prognostic marker in thepatient's reproductive history. Integration of RPS-SCORE™ into the clinical protocol increases theaccuracy of predicting outcomes in subsequent ART cycles and reduces the frequency of recurrent lossesby 34–42% (p<0.05).

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