Actively Recruiting
The Impact of the Frame17 Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study
Led by Inception Fertility Research Institute, LLC · Updated on 2026-04-15
400
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
I
Inception Fertility Research Institute, LLC
Lead Sponsor
R
Reframe Health, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, controlled pilot study to evaluate the impact of the FRAME platform on women experiencing fertility issues and emotional stress. This study will enroll approximately 400 women who have completed an initial consultation at participating fertility clinics. The purpose is to assess how the use of FRAME influences patient retention and emotional well-being during fertility care. Participants will be randomly assigned to one of two groups. The control group will receive no additional intervention and continue their usual fertility care for six months. The intervention group will have access to FRAME, a digital platform offering resources, education, and support from a dedicated care team, including board-certified fertility coaches. They are encouraged to use FRAME for six months alongside their fertility care. All participants will complete psychological questionnaires at enrollment and after six months, including measures like the Perceived Stress Scale, Personal Health Questionnaire Depression Scale, and Fertility Problem Stress Scale. Medical records will be reviewed for up to nine months post-enrollment to track fertility treatment initiation and timing. The primary outcome is whether fertility treatment starts within about six months, with secondary outcomes including the time to treatment start. This study also monitors participants' emotional health and retention in fertility care.
CONDITIONS
Brief Title
Frame Support Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Participants are female aged 22 to 44 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete psychological questionnaires including the Perceived Stress Scale (PSS), the Personal Health Questionnaire Depression Scale (PHQ-8), and the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) at enrollment.
1 visit (in-person or virtual)
Duration - 6 months
Participants are randomized to either receive access to FRAME, a collaborative care platform with fertility coaching and resources, or to the control group with no additional action. The intervention group is encouraged to use FRAME resources during fertility care.
Regular use of FRAME platform encouraged for intervention group; control group has no additional visits for the intervention
Duration - 1 day
Participants in both groups complete a post-study psychological questionnaire to assess emotional health after 6 months.
1 visit (in-person or virtual)
Duration - Up to 9 months post enrollment
Data from participants' medical records are collected for up to nine months after enrollment to evaluate fertility treatment initiation and timing.
Trial Site Locations
Total: 1 location
1
Inception Fertility Research Institute
Houston, Texas, United States, 77081
Actively Recruiting
Research Team
A
Amber Mendoza
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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