Patient Empowerment Project (PEP) Study

NCT07725458 | Not Yet Recruiting

• 1 other identifier: IRI-PEP-2026-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infertility; Mental Health

Keywords

Infertility; Mental health; Assistive Reproductive Technology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention

The PEP questionnaire will be implemented at the intervention clinic and staff will receive training to address responses.

Behavioral: Patient Empowerment Program (PEP)

Control

Patients at the Control clinic will receive standard of care with no changes or additional questionnaires.

Interventions

Patient Empowerment Program (PEP) BEHAVIORAL

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 and the PEP Questionnaire will be included in the 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking fertility treatment at participating clinics

Patients seeking fertility treatment at participating clinics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Inception Fertility Research Institute, LLC: lead

Study Sites (2)

The Reproductive Medicine Group

Tampa, Florida, 33609, United States

Location

Aspire Fertility Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Infertility; Psychological Well-Being

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Personal Satisfaction; Behavior

Central Study Contacts

Laurel Anderson, BS

CONTACT

3463621476; landerson@inceptionllc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)