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

Authors

  • Tracey Parnell International Institute for Restorative Reproductive Medicine, Crawley, West Sussex, UK; Department of Family Practice, University of British Columbia, Vancouver, B.C., Canada https://orcid.org/0009-0007-4226-1582
  • Monica Minjeur International Institute for Restorative Reproductive Medicine, Crawley, West Sussex, UK; Radiant Clinic, Cedar Rapids, IA, USA https://orcid.org/0009-0005-6183-8258
  • Craig Turczynski RRM Diagnostics, Dallas, TX , USA , Duquesne University College of Osteopathic Medicine, Pittsburgh, PA, USA https://orcid.org/0000-0001-7658-9470
  • Tony Pistilli Axene Health Partners, McKinney, Texas, USA https://orcid.org/0009-0005-6982-2031

DOI:

https://doi.org/10.63264/r27a3q62

Keywords:

infertility, guideline adherence, reproductive endocrinology, restorative reproducitve medicine, diagnosis-directed care, claims analysis, in vitro fertilization, ASRM, AUA/ASRM

Abstract

Objective: To evaluate adherence to published American Society for Reproductive Medicine (ASRM) and American Urological Association (AUA) 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 selected diagnostic testing, medical treatment, or surgical interventions recommended by ASRM or AUA/ASRM guidance for specific infertility-related diagnoses before IVF initiation. Cumulative adherence rates were assessed up to nine months following initial infertility diagnosis and compared with the timing of initiating IVF.

Results: IVF initiation started early and consistently preceded completion of most recommended evaluations and treatments. By 3 months, the proportion of patients with IVF initiation ranged from 28% to 39% across different infertility-related diagnoses, while adherence to most recommended interventions remained low. Overall, by 9 months, IVF utilization had reached 70–85%, while many recommended evaluations and treatments remained below 40% adherence, with several interventions remaining below 15%. Observed care gaps (percentage of patients receiving IVF prior to other evaluation or treatment recommendations) ranged from approximately 13% to 78% for most recommended evaluations and treatments, with several measures demonstrating gaps over 50% of patients.

Discussion: These findings suggest substantial divergence between published infertility-care recommendations and observed practice patterns. From the perspective of restorative reproductive medicine (RRM), the gaps are clinically important because many recommended steps are directed toward identifying, correcting, restoring, or preserving reproductive function and anatomy before offering or initiating IVF treatment. Limitations to these data include lack of individualized patient medical data, preferences, or circumstances, and not capturing any treatment that was not reimbursed by commercial insurance (i.e., any cash payment for services). In addition, the recommendations assessed have variable levels of underlying evidence, and likely vary in the level of their acceptance among practicing clinicians.

Conclusions: Many commercially insured infertility patients progressed to IVF without documented evidence of diagnostic evaluation or therapeutic interventions recommended in ASRM and AUA/ASRM guidance. These findings raise important questions regarding the implementation of adequate evaluation 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 RRM 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 considering IVF.

References

1. Arraztoa JA. Commentary on Infertility and Restorative Reproductive Medicine. J Restorative Reprod Med (2025) 1:1–5. doi: 10.63264/7eg52623.

2. McLernon DJ, Lee AJ, Maheshwari A, van Eekelen R, van Geloven N, Putter H, et al. Predicting the Chances of Having a Baby with or without Treatment at Different Time Points in Couples with Unexplained Subfertility. Hum Reprod (2019) 34(6):1126–38. doi:10.1093/humrep/dez049.

3. Centers for Disease Control and Prevention. National ART Surveillance System (NASS). https://artreporting.cdc.gov/Default.aspx

4. Practice Committee of the American Society for Reproductive Medicine. Fertility evaluation of infertile women: a committee opinion. Fertil Steril. 2021 Nov;116(5):1255-1265. doi:10.1016/j.fertnstert.2021.08.038.

5. Teede HJ, Tay CT, Laven JJE, et al. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023;120(4):767–793. doi: doi.org/10.1016/j.fertnstert.2023.07.025

6. Practice Committee of the American Society for Reproductive Medicine. Current evaluation of amenorrhea: a committee opinion. Fertil Steril. 2024 Jul;122(1):52-61. doi: 10.1016/j.fertnstert.2024.02.001.

7. Practice Committee of the American Society for Reproductive Medicine. Endometriosis and infertility: a committee opinion. Fertil Steril. 2012 Sep;98(3):591-8. doi: 10.1016/j.fertnstert.2012.05.031.

8. Schlegel PN, Sigman M, Collura B, De Jonge CJ, Eisenberg ML, Lamb DJ, Mulhall JP, Niederberger C, Sandlow JI, Sokol RZ, Spandorfer SD, Tanrikut C, Treadwell JR, Oristaglio JT, Zini A. Diagnosis and treatment of infertility in men: AUA/ASRM guideline part I. Fertil Steril. 2021 Jan;115(1):54-61. doi:10.1016/j.fertnstert.2020.11.015.

9. Schlegel PN, Sigman M, Collura B, De Jonge CJ, Eisenberg ML, Lamb DJ, Mulhall JP, Niederberger C, Sandlow JI, Sokol RZ, Spandorfer SD, Tanrikut C, Treadwell JR, Oristaglio JT, Zini A. Diagnosis and treatment of infertility in men: AUA/ASRM guideline part II. Fertil Steril. 2021 Jan;115(1):62-69. doi: 10.1016/j.fertnstert.2020.11.016. Epub 2020 Dec 9. PMID: 33309061.

10. Boyle PC, de Groot T, Andralojc KM, Parnell TA. Healthy Singleton Pregnancies From Restorative Reproductive Medicine (RRM) After Failed IVF. Front Med (Lausanne). 2018 Jul 31;5:210. doi:10.3389/fmed.2018.00210.

11. Boyle P, Toth A, Minjeur M, Turczynski C (2025). Restorative reproductive medicine (RRM) outcomes compared to in-vitro fertilization (IVF) for the treatment of infertility: a retrospective evaluation of a 2019 clinic cohort compared to one cycle of IVF. Journal of Restorative Reproductive Medicine, 2025: 1,1-15. https://doi.org/10.63264/gejytw70

12. Carrot Fertility. Beyond IVF: what people really want from fertility care [Internet]. West Des Moines (IA): Carrot Fertility, Inc.; 2026 Mar 31 [cited 2026 Jun]. Available from: https://www.get-carrot.com/blog/beyond-ivf-report

13. Parnell TA, Copeland K, Minjeur M. Public Awareness, Perceptions, and Preferences in Fertility Treatment: Secondary Analysis of Two Public Surveys. J Restorative Reprod Med. 2026;2:1–20. doi:10.63264/6yy3mw82.

14. American Society for Reproductive Medicine. Just the Facts: “Restorative Reproductive Medicine” and “Ethical IVF” are Misleading Terms That Threaten Access. Birmingham (AL): ASRM; 2025. Available from: ASRM Fact Sheet (https://www.asrm.org/advocacy-and-policy/fact-sheets-and-one-pagers/just-the-facts-restorative-reproductive-medicine-and-ethical-ivf-are-misleading-terms-that-threaten-access/)

15. Riley GF. Administrative and claims records as sources of health care cost data. Med Care. 2009 Jul;47(7 Suppl 1):S51-5. doi: 10.1097/MLR.0b013e31819c95aa.

16. Stamas N, Vincent T, Evans K, Li Q, Danielson V, Lassagne R, Berger A. Use of Healthcare Claims Data to Generate Real-World Evidence on Patients With Drug-Resistant Epilepsy: Practical Considerations for Research. J Health Econ Outcomes Res. 2024 Feb 27;11(1):57-66. doi: 10.36469/001c.91991.

17. Langan SM, Schmidt SA, Wing K, Ehrenstein V, Nicholls SG, Filion KB, Klungel O, Petersen I, Sorensen HT, Dixon WG, Guttmann A, Harron K, Hemkens LG, Moher D, Schneeweiss S, Smeeth L, Sturkenboom M, von Elm E, Wang SV, Benchimol EI. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018 Nov 14;363:k3532. doi: 10.1136/bmj.k3532.

18. Jonklaas J, Bianco AC et al. 2014. American Thyroid Association Task Force on Thyroid Hormone Replacement. Guidelines for the treatment of hypothyroidism: prepared by the American thyroid association task force on thyroid hormone replacement. Thyroid. Dec;24(12):1670-751. doi:10.1089/thy.2014.0028.

19. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001.

20. Endalamaw A, Khatri RB, Mengistu TS, Erku D, Wolka E, Zewdie A, Assefa Y. A scoping review of continuous quality improvement in healthcare system: conceptualization, models and tools, barriers and facilitators, and impact. BMC Health Serv Res. 2024 Apr 19;24(1):487. doi: 10.1186/s12913-024-10828-0..

21. McDonald KM, Sundaram V, Bravata DM, Lewis R, Lin N, Kraft SA, McKinnon M, Paguntalan H, Owens DK. Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies (Vol. 7: Care Coordination). Rockville (MD): Agency for Healthcare Research and Quality (US); 2007 Jun. Report No.: 04(07)-0051-7.

22. Pathare S, Brazinova A, Levav I. Care gap: a comprehensive measure to quantify unmet needs in mental health. Epidemiol Psychiatr Sci. 2018;27(5):463-467. Available from: http://pmc.ncbi.nlm.nih.gov/articles/PMC6999014

23. Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi:10.1001/jama.282.15.1458.

24. Choy JT, Eisenberg ML. Male infertility as a window to health. Fertil Steril. 2018 Oct;110(5):810-814. doi:10.1016/j.fertnstert.2018.08.015.

25. Stentz NC, Koelper N, Barnhart KT, Sammel MD, Senapati S. Infertility and mortality. Am J Obstet Gynecol. 2020 Mar;222(3):251.e1-251.e10. doi:10.1016/j.ajog.2019.09.007.

26. Wilson JF, Kopitzke EJ. Stress and infertility. Curr Womens Health Rep. 2002 Jun;2(3):194-9.

27. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348(26):2635-2645.

28. Oliveira CJ, José HMG, Costa EIMTD. Medication Adherence in Adults with Chronic Diseases in Primary Healthcare: A Quality Improvement Project. Nurs Rep. 2024 Jul 17;14(3):1735-1749. doi:10.3390/nursrep14030129.

29. Stanford JB, Parnell TA, Boyle PC. Outcomes from treatment of infertility with natural procreative technology in an Irish general practice. J Am Board Fam Med. 2008 Sep-Oct;21(5):375-84. doi:10.3122/jabfm.2008.05.070239.

30. Huang LN, Tan J, Hitkari J, Dahan MH. Should IVF be used as first-line treatment or as a last resort? A debate presented at the 2013 Canadian Fertility and Andrology Society meeting. Reprod Biomed Online. 2015 Feb;30(2):128-36. doi:10.1016/j.rbmo.2014.10.004.

31. Boltz MW, Sanders JN, Simonsen SE, Stanford JB. Fertility Treatment, Use of in Vitro Fertilization, and Time to Live Birth Based on Initial Provider Type. J Am Board Fam Med. 2017 Mar-Apr;30(2):230-238. doi:10.3122/jabfm.2017.02.160184.

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Published

2026-07-13

Data Availability Statement

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.

How to Cite

Parnell, T., Minjeur, M., Turczynski, C., & Pistilli, T. (2026). 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. Journal of Restorative Reproductive Medicine, 2, 1-15. https://doi.org/10.63264/r27a3q62

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