Original Research
Real World Fertility Evaluation & Care Prior to In Vitro Fertilization: Care Gaps That Could be Addressed by Restorative Reproductive Medicine
A Retrospective 5-Million Patient Claims Based Care-Gap Analysis
Author affiliations
- International Institute for Restorative Reproductive Medicine, Crawley, West Sussex, UK
- Department of Family Practice, University of British Columbia, Vancouver, British Columbia, Canada
- Radiant Clinic, Cedar Rapids, IA, USA
- RRM Diagnostics, Dallas, TX , USA
- Duquesne University College of Osteopathic Medicine, Pittsburgh, PA, USA
- Axene Health Partners, McKinney, Texas, USA
ORIGINAL MANUSCRIPT— NOT YET PEER REVIEWED This manuscript is currently under peer review. If the article is published, this page will be updated with a link to the final peer-reviewed version of record, which may differ from the version provided here.
Abstract
Objective
To evaluate adherence to published American Society for Reproductive Medicine (ASRM) infertility evaluation and treatment recommendations among commercially insured infertility patients who subsequently underwent in vitro fertilization (IVF) and to assess whether observed care gaps support the need for a restorative reproductive medical framework.
Methods
A retrospective claims-based analysis was performed using MarketScan® Commercial Claims and Encounter Data between January 1, 2021, and December 31, 2024. Approximately five million commercially insured members were evaluated. Patients with infertility-related diagnoses who subsequently underwent IVF were identified. Claims were analyzed for evidence of diagnostic testing, medical treatment, or surgical intervention recommended by ASRM or AUA/ASRM guidance before IVF initiation. Cumulative adherence rates were assessed over nine months following initial infertility diagnosis.
Results
IVF initiation rose early and consistently exceeded completion of nearly all guideline-recommended evaluations and treatments. Observed care gaps ranged from approximately 13% to 78% for most recommended evaluations and treatments, with several measures demonstrating gaps exceeding 50 percentage points, suggesting substantial divergence between guideline recommendations and observed clinical practice. By 3 months, IVF initiation ranged from 28% to 39% across cohorts, while adherence to many recommended interventions remained low. Overall, by 9 months, IVF utilization commonly exceeded 70–85%, while many guideline-supported evaluations and treatments remained below 40% adherence, with several interventions remaining below 15%.
These findings suggest substantial divergence between published infertility-care recommendations and observed pre-IVF practice patterns. From an RRM perspective, the gaps are clinically important because many recommended steps are directed toward identifying, correcting, restoring, or preserving reproductive function and anatomy before reproductive barriers are bypassed through IVF.
Conclusions
Many commercially insured infertility patients appeared to progress to IVF without documented evidence of diagnostic evaluation or therapeutic intervention recommended in ASRM and AUA/ASRM guidance. These findings raise important questions regarding the implementation of infertility guidelines before IVF and the extent to which patients receive meaningful opportunities for diagnosis-directed treatment of potentially reversible causes of infertility. The findings further suggest an important role for restorative reproductive medicine as a quality-of-care framework focused on comprehensive evaluation, correction of underlying dysfunction, preservation of reproductive anatomy and physiology, and optimization of patient-centered fertility care prior to attempts with assisted reproduction.
Keywords: infertility; in vitro fertilization; IVF; ASRM; AUA/ASRM; guideline adherence; reproductive endocrinology; restorative reproductive medicine; RRM; diagnosis-directed care; claims analysis.
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Funding
The original study was conceived of and funded by the Women’s Reproductive Health Foundation (WRHF). Axene Health Partners was commissioned by WRHF to perform the actuarial analysis.
Disclosures
The authors declare no competing financial interests related to this manuscript. The actuarial analysis was performed by Axene Health Partners under contract with WRHF. M.M. is an unpaid member of the executive team of NeoFertility LLC. T.A.P. serves as the Medical Director of RRMed (unpaid).
Ethics Approval
This study utilized de-identified administrative claims data. No direct patient contact occurred, and no identifiable personal health information was accessed by the investigators.
Data Availability
The MarketScan® Commercial Claims and Encounter Database used for this study is proprietary and subject to licensing restrictions. Data may be available from the data owner subject to applicable agreements and permissions.
© 2026 The Authors. This manuscript version is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). This manuscript is currently under peer review. If published, this page will be updated to link to the final version of record, which may differ from this version.
