RecruitingNot ApplicableNCT07083700

Frame Support Study

The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study

Sponsor

Inception Fertility Research Institute, LLC

Enrollment

400 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Emotional Stress Fertility Issues

Summary

This is a randomized, controlled pilot study evaluating an intervention of non-significant risk. Potential subjects will be women who have completed an initial new patient consultation at one of the participating fertility clinics. Approximately 400 subjects will be enrolled from multiple fertility clinics.

Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 44 Years

Inclusion Criteria3

Participants have completed a new patient consult at one of the participating fertility clinics
Participants must be able to read, write and speak English
Participants must have access to a smart phone and internet connection

Exclusion Criteria5

Patients who are currently using a fertility coach (in-person, remote, or online)
Patients planning egg freezing only
Patients who have received treatment at another fertility center
Patients planning egg donation
Patients currently participating in another clinical trial or study involving an intervention.

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Interventions

BEHAVIORALFrame Access

FRAME™ provides a collaborative care platform that connects patients with evidence-based resources, education and support from a dedicated care team throughout their reproductive health care journey. More specifically, for patients exploring fertility treatment. Frame supplements the patient experience by providing patients with direct contact to board-certified fertility coaches and resources that can be accessed between appointments in a web-based application. Regular use of Frame's platform may help patients make lifestyle changes that can improve their fertility outcomes as well as boost their emotional health throughout the treatment process and reduce feelings of overwhelm and loneliness which can lead to patients dropping out of care.