Patient Empowerment Project (PEP) Study (PEP)

Efficacy of an Infertility Patient Empowerment Project (PEP), a Pilot Study

The Patient Empowerment Project (PEP) will be integrated into the intake process at a fertility clinic to prepare clinical staff for any patient sensitivities or preferences and provide extra support if needed. The study will evaluate if the PEP increases patient retention and patient satisfaction scores.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; Mental Health
• Intervention / Treatment: Behavioral: Patient Empowerment Program (PEP)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Laurel Anderson, BS; Phone Number: 3463621476; Email: landerson@inceptionllc.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33609
      • The Reproductive Medicine Group
      • Contact: Laurel Anderson, BS; Phone Number: 3463621476; Email: landerson@inceptionllc.com
  • Texas
    • Dallas, Texas, United States, 75247
      • Aspire Fertility Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients seeking fertility treatment at participating clinics

Description

Patients seeking fertility treatment at participating clinics

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; The PEP questionnaire will be implemented at the intervention clinic and staff will receive training to address responses.	Behavioral: Patient Empowerment Program (PEP); The clinic staff will receive PEP training from a licensed psychologist (the PI). PEP will be implemented, starting after training is complete. The PEP Introduction (Appendix A) and the PEP Questionnaire (Appendix B) will be included on the online New Patient Packet. The patient will complete the PEP questionnaire as they complete their new patient intake forms. Clinic staff will tailor their approach to the patient based on the patient's responses to the questionnaire.
Control; Patients at the Control clinic will receive standard of care with no changes or additional questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Standard patient satisfaction surveys will be collected at regular intervals throughout the study period	New Patient consultation to 6 months later
Patient Retention Rate	Patient retention is measured by the percentage of patients who attended a new patient consult and moved forward with treatment.	New patient consultation to 6 months later

Collaborators and Investigators

• Sponsor: Inception Fertility Research Institute, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Infertility; Mental health; Assistive Reproductive Technology
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Behavior; Personal Satisfaction; Infertility; Psychological Well-Being
• Other Study ID Numbers: IRI-PEP-2026-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No