Clinical Rationale Why Integrate RI Patient Selection How Ordering Works
For Reproductive Endocrinologists & Fertility Specialists

Immune Insights for MorePersonalized Fertility Care

Why do some patients continue to fail despite euploid embryos, a receptive endometrium, and normal anatomy?

The answer may lie beyond traditional fertility assessments.

Pregmune offers a comprehensive reproductive immunology evaluation designed to help physicians identify immune-related factors that may contribute to recurrent implantation failure, pregnancy loss, and other unexplained reproductive challenges.

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Up to 80%
of unexplained RIF cases have been shown to involve immune mechanisms1
1 in 4
pregnancies end in miscarriage — up to 60% of RPL cases remain unexplained
55+
biomarkers analyzed by Pregmune — full report delivered within 5 weeks
30%
absolute increase in pregnancy success rate achieved in patients >37 yrs in a single center study
Clinical Rationale for Reproductive Immunology

The Missing Piece in Fertility Evaluation

Standard fertility evaluations — including hormonal testing, semen analysis, imaging, and genetic screening — are highly effective at identifying structural, endocrine, and chromosomal causes of infertility. Yet despite their sophistication, immune evaluation is still largely absent from routine fertility workups.

For patients who continue to experience implantation failure or pregnancy loss despite reassuring conventional results, immune dysregulation is no longer a fringe concept. Increasing evidence suggests it may represent one of the most clinically relevant yet underexplored contributors to reproductive failure.

Successful Pregnancy IMMUNE SYSTEM PREGMUNE'S FOCUS EMBRYO ENDOMETRIAL RECEPTIVITY
01
The Diagnostic Gap Is Real
Standard fertility workups — hormonal panels, semen analysis, sonography — don't assess the immune system. Yet immune factors have been implicated in 30–60% of unexplained infertility and RPL cases. Pregmune closes that gap with a single, comprehensive assessment.
02
Immune Mechanisms Are Established
NK cell cytotoxicity, Th1/Th2 imbalance, regulatory T cell deficiency, antiphospholipid antibodies, and KIR-HLA-C mismatches are each individually linked to reproductive failure in peer-reviewed literature spanning multiple decades.
03
Guidelines Are Catching Up
ESHRE's 2023 RPL guidelines explicitly acknowledge immune mechanisms and, for the first time, recognize a role for IVIG in select RPL patients. ASRM is actively updating its unexplained infertility guidance. The field is moving — and your most challenging patients are waiting.
04
Treatments Exist
Identifying immune factors is clinically meaningful because evidence-based treatments are available — from low-dose prednisolone and IVIG for NK cell dysregulation to heparin for thrombophilic markers and G-CSF for Treg support.
Why Integrate Reproductive Immunology

Why Physicians Choose Pregmune

Most fertility specialists aren't trained in immunology — and shouldn't need to be. Pregmune translates complex immune biology into clear, actionable findings that fit naturally into your existing practice, giving patients a fuller picture and a path forward.

Help More Patients Achieve Pregnancy
Identify and address immune contributors that standard workups miss — giving patients with repeated failures a new path forward. Optimizing the immune environment before transfer may improve live birth outcomes, particularly in advanced maternal age and refractory cases.
Enable Precision-Guided Treatment Plans
Move beyond empirical treatment approaches with comprehensive immune profiling that provides actionable insights to support individualized, evidence-informed therapeutic decisions tailored to each patient's unique reproductive profile.
Provide Answers for Unexplained Failure
Give patients with unexplained infertility, recurrent loss, or implantation failure an explanation — and a plan — when conventional workups come back normal.

Initial real-world data from a single clinical center suggest meaningful improvements in pregnancy outcomes for patients evaluated with Pregmune.

See Real-World Evidence →
Patient Selection

When to Refer

Pregmune is not a first-line screen — it is indicated for patients who present with specific clinical histories where immune dysfunction is most likely to be a contributing factor.

Endometriosis or PCOS
Associated with systemic inflammation and immune dysregulation that can impair implantation beyond the structural mechanisms routinely treated — even when surgical management appears complete.
Limited Eggs or Embryos
When available embryos are few, optimizing the immune environment before transfer is especially critical. Immune dysregulation may reduce the chances of success even from a viable embryo — making each transfer opportunity count.
Autoimmune or Thrombophilic History
Known or suspected autoimmune conditions (lupus, thyroiditis, APS), or personal/family history of thrombosis. These directly overlap with immune mechanisms in reproduction.
RIF — Recurrent Implantation Failure
≥2 failed transfers with good-quality embryos, including with donor eggs. Immune abnormalities implicated in 30–40% of cases.
RPL — Recurrent Pregnancy Loss
≥2 consecutive miscarriages. Immune dysregulation is among the leading proposed contributors, implicated in an estimated 30–50% of RPL cases.
Unexplained Infertility
Infertility with no identifiable cause after standard workup. Immune dysfunction is one of the most plausible and understudied explanatory factors.

What Physicians Ask Before Ordering

Clinical Basis
Pregmune is not intended for routine infertility screening. It's designed for patients with RPL, RIF, or unexplained infertility — cases where immune dysregulation may be contributing and where the evidence for immune evaluation is strongest. The report clearly distinguishes where guideline-supported evidence exists from where data are still emerging, helping you weigh potential benefits and uncertainties when discussing options with patients. Treatment considerations are based on published literature, current guidelines where available, and expert review, and are intended to support — not replace — your clinical judgment.
Most practices order a handful of immune or thrombophilia tests — typically 3 to 8 markers. Pregmune evaluates more than 55 biomarkers across six immune domains and uses AI to identify clinically meaningful patterns across all of them. Rather than isolated lab values, you receive a single integrated interpretation prioritized for clinical relevance. It complements, rather than duplicates, your existing workup by evaluating immune pathways — KIR-HLA compatibility, NK cell activity, Th1/Th2 balance, regulatory T cells — that aren't part of routine fertility assessments.
Patient Selection and Management
Pregmune is intended for patients in whom immune dysregulation is reasonably suspected: recurrent pregnancy loss, recurrent implantation failure, unexplained infertility, repeated IVF failure, or autoimmune conditions that may affect reproductive outcomes. It is not intended as a universal infertility screen.
Pregmune is often most useful after a standard infertility evaluation is unrevealing, or before additional IVF cycles following repeated treatment failure. Earlier testing may also make sense when immune dysfunction is suspected or when reproductive opportunities are limited — for example, diminished ovarian reserve or few remaining embryos.
Pregmune doesn't prescribe treatment. It provides evidence-referenced clinical considerations to help inform management decisions that remain yours. Where guideline-supported therapies exist, they're clearly identified. For emerging areas, the report summarizes available evidence so you can decide what's appropriate for each patient.
Practice Workflow
Pregmune manages benefits verification, patient communication, blood draw logistics, and report delivery, minimizing work for the practice. The goal is to make ordering and implementation as straightforward as any specialty diagnostic consultation.
We've designed Pregmune to integrate seamlessly into routine practice. Once a patient is referred, Pregmune manages the process through report delivery—providing a concise, physician-ready report within a few weeks. Physicians don't need specialized expertise in reproductive immunology to use Pregmune effectively, and our Medical Affairs team is available to discuss complex cases. The result is as straightforward as any specialty diagnostic consultation.
Reports are delivered within five weeks after all required specimens are received, allowing results to be incorporated into upcoming treatment planning without significant delay.
The Process

How Ordering Works

Pregmune is designed to fit into your clinical workflow with minimal friction. Here's how it works from referral to report.

1

Refer a Patient

We handle patient intake and benefits verification to ensure a streamlined experience.

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2

Lab Coordination

Pregmune coordinates lab draws through LabCorp and ReproSource — no internal lab management, no requisition burden on your team.

3

IRMA Analysis

55+ biomarkers are analyzed by our proprietary algorithm and reviewed by the Pregmune scientific team for clinical accuracy and completeness.

4

Report Delivery

A full report is delivered to you and your patient within 5 weeks, with findings, clinical flags, and treatment considerations.

How Pregmune Supports You

  • All patient benefits verification and prior authorization work handled by Pregmune
  • All lab work coordinated through LabCorp and ReproSource — no internal lab management or requisition burden
  • Reports consolidate all biomarker results into a simple summary of clinically flagged findings and evidence-referenced treatment pathway considerations
  • One-on-one consultation with a PhD reproductive immunology expert to review patient-specific findings
  • Access to REIs experienced in using Pregmune reports and available to share practical guidance on clinical implementation and treatment protocols

Benefits to Your Practice

Expand your diagnostic toolbox
Offer comprehensive immune profiling for your most challenging and underserved patient population
Deliver more personalized treatment plans
Integrated immune data rather than empirical protocols supports individualized therapeutic decisions for each patient
Improve patient satisfaction and retention
Provide answers and a plan when standard workups come back normal. Patients with explanations are consistently more satisfied and likely to continue care
Differentiate your practice
Position your program as a leader in advanced, personalized fertility care

Clinical Note: Pregmune is a complement, not a replacement

Pregmune is designed to integrate with your existing workup and protocol — not to displace your clinical judgment. Reports are delivered in a format designed for physician review, with biomarker results, reference ranges, flagged findings, and evidence-referenced treatment considerations.

Get Started

Ready to discuss Pregmune for your practice?

Our Medical Affairs team is available to answer clinical questions, discuss specific cases, and walk through the referral process.

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Medical Disclaimer

Patients and physicians should always consult with a licensed medical professional before making any clinical decisions, including starting or discontinuing any treatment. Any information provided by Pregmune, including but not limited to the IRMA Report, AIMY Report, test results, risk estimates, supporting documentation, email communications or other related content (collectively, "Pregmune Content"), is intended for informational purposes only. This content is not medical advice and should not be used as a substitute for professional medical evaluation, diagnosis, or treatment. Pregmune Content is not a recommendation for any specific treatment plan, therapy, medication, or course of action. It is designed to support, not replace, the relationship between patients and their qualified healthcare providers. Pregmune does not provide medical care, and its reports and communications should never delay or override clinical judgment.