The Surveillance of Treatment Outcomes in Restorative Reproductive Medicine (STORRM) project is an international registry developed by the International Institute for Restorative Reproductive Medicine (IIRRM) in collaboration with the University of Utah School of Medicine. It is directed by Joseph Stanford, MD. The registry is a unique and essential resource for clinical decision-making, clinical practice advancement, associated research, and public health.

Background: One of IIRRM’s first undertakings was the International Natural Procreative Technology Evaluation and Surveillance of Treatment for Subfertility (iNEST)1, a practice-based research study registered with clinicaltrials.gov. This study was the first multicentre study of clinics employing a restorative reproductive medicine approach for subfertility and was conducted over a 10-year span from 2006–2016. INEST has provided insights into prognostic factors influencing pregnancy and live birth outcomes, and served as a valuable learning experience for future multicentre studies, including STORRM. Data collected through iNEST continue to be analysed for publication.

The STORRM research registry was officially launched on March 11, 2023, at the IIRRM Congress in Lisbon, with additional participating centres and practices being added on an ongoing basis.

Objectives: As our initial activity, we have established the registry for restorative reproductive medicine (RRM) treatments for subfertility and miscarriage, and the outcomes of treatment. The primary outcome is a healthy live birth. Data will be de-identified and presented publicly in summary form, and also be available for research analysis and publication. This will allow patients, clinicians, and other interested parties to be informed about current practice and outcomes.

We expect the STORRM registry to:

  • help address the enormous need of subfertile couples for restorative treatment options that are viable, effective, cost-effective, healthy, and consistent with all ethical values, while reducing or avoiding unnecessary interventions.
  • provide reliable data that can be used to inform clinicians and patients about the probability of a live birth with RRM treatment, based on a couple’s clinical characteristics.
  • provide reliable outcomes data to support third-party reimbursement for RRM services.
  • compare outcomes (e.g., live birth rates) across countries, regions, clinics, and different developed and developing systems or approaches of RRM.*  This will support participating clinicians who wish to learn from each other to improve the practice of RRM.
  • document improvements and changes in outcomes over time with changes in RRM practice and treatment.
  • develop pilot data and infrastructure to inform future clinical trials of specific evaluations or interventions.
  • raise visibility for RRM options for patients, clinicians, and other interested parties.

*Developed and developing systems or approaches of RRM include, but are not limited to, NaProTechnology (with Creighton Model FertilityCare), Fertility Education and Medical Management (FEMM)/Reproductive Health Research Institute, NeoFertility, Billings Ovulation Method medical applications, Marquette Model medical applications, and Sensiplan medical applications.

Prospective participants: Participation in the STORRM registry is currently restricted to individuals and clinical centres holding active membership with the International Institute for Restorative Reproductive Medicine (IIRRM).  Consistent with best practices for clinical research networks and registries, this ensures ensures alignment with research standards, access to study infrastructure, and supports the quality and comparability of contributed data across participating sites.2   This standardization can also help facilitate collaborative analysis, dissemination, and future development of multicentre research initiatives.  If you are not yet a member, and interested in participating in STORRM, we invite you to apply for membership here.

 

[1] Joseph B Stanford and others, International Natural Procreative Technology Evaluation and Surveillance of Treatment for Subfertility (iNEST): enrollment and methods, Human Reproduction Open, Volume 2022, Issue 3, 2022, hoac033, https://doi.org/10.1093/hropen/hoac033

[2] Gliklich RE, Leavy MB, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User’s Guide. 4th edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Sep. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562575/