Frame Support Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-44
SponsorInception Fertility Research Institute, LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Frame Access
BehavioralFRAME™ 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Frame AccessExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fertility treatment initiation
To observe whether the patient started fertility treatment.
Time frame
This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.Secondary outcomes
1
Time to fertility treatment initiation
To observe the interval between study enrollment and start fertility treatment, if any.
Time frame
This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.Other outcomes
1
Patient Health Questionnaire (PHQ-8)
Patients will complete the Patient Health Questionnaire (PHQ-8) for depression screening at baseline and end of study. Scores of 10 and above suggest the presence of Major Depressive Disorder with higher scores being more severe.
Time frame
From enrollment to six months after enrollment2
Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS)
Patients will complete the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) at baseline and end of study. Lower scores indicate lower stress.
Time frame
From enrollment to 6 months after enrollment.3
Perceived Stress Scale (PSS-10)
Patients will complete the Perceived Stress Scale (PSS-10) at baseline and end of study. Scores will be interpreted as 0-13: Low stress; 14-26: Moderate stress; 27-40: High perceived stress.
Time frame
From enrollment to 6 months after enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Inception Fertility Research Institute, LLC
Lead sponsor
Reframe Health, Inc.
Collaborator
Source ClinicalTrials.gov