FRAME support for women undergoing fertility care

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

This pilot will test whether giving women access to the FRAME app and an external support team for six months reduces stress and improves emotional well-being during fertility care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 22 Years to 44 Years
• Sex: Female
• Sponsor: Inception Fertility Research Institute, LLC (industry)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07083700 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled pilot enrolling about 400 women who have completed a new patient consult at participating fertility clinics. Participants complete baseline questionnaires (PSS, PHQ-8, COMPI-FPSS) and are randomized 1:1 to either usual care or to receive access to FRAME and its external care team for six months. The intervention group is encouraged to use FRAME and its resources during that period while the control group is asked to take no additional action. Outcomes are measured with a six-month post-study psychological questionnaire and medical record data collected up to nine months after enrollment.

Who should consider this trial

Good fit: Ideal candidates are women who have completed a new patient consult at a participating fertility clinic, can read, write, and speak English, have a smartphone and internet access, and are not currently using a fertility coach, not planning egg freezing or donation only, have not received treatment at another fertility center, and are not enrolled in another interventional trial.

Not a fit: Patients who are planning egg freezing or donation only, are already using a fertility coach, have received treatment elsewhere, lack smartphone/internet access, or are in another interventional study are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the intervention could lower stress and improve emotional well-being for people navigating fertility treatment.

How similar studies have performed: Previous digital and coaching interventions for fertility-related stress have shown modest improvements in stress and mood in smaller studies, but robust randomized evidence is still limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Houston, Texas

• Inception Fertility Research Institute — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Amber Mendoza

Conditions: Fertility Issues, Emotional Stress