FRAME support for women undergoing fertility care
Official title: The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study
Run by Inception Fertility Research Institute, LLC · NCT07083700 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 44 Years |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | Inception Fertility Research Institute, LLC Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | June 23, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07083700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Inception Fertility Research Institute
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Amber Mendoza
- Email: amendoza@inceptionllc.com
- Phone: 346-393-2265
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.