Frame Support Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frame Access.
- Who it may be relevant to
- Registry conditions: Fertility Issues, Emotional Stress. Basic parameters: 22 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study
Overview
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.
Detailed description
All participants will complete a psychological questionnaire at enrollment. The questionnaire will include 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). Participants will then be randomized 1:1 to the control group or intervention group. Participants in the control group will not be asked to take any additional action for six months. Participants in the intervention group will be given access to FRAME which will provide them with resources and an external care team to utilize during their fertility care. The intervention group is encouraged to use FRAME and its resources for six months. After six months, participants in both groups will complete a post-study psychological questionnaire. Data will be collected from medical records of all participants for up to nine months after enrollment.
Interventions
- Behavioral Frame 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 m
Primary outcome measures
- Fertility treatment initiation [Time frame: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.]
Secondary outcome measures (1)
- Time to fertility treatment initiation [Time frame: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Inception Fertility Research Institute — Houston
Identifiers
NCT: NCT07083700 · IRI-RH-2025-001