Emotional Stress, Fertility Issues
Conditions
Brief summary
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
BEHAVIORALFrame 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 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.
Sponsors
Inception Fertility Research Institute, LLC
Reframe Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility treatment initiation | This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment. | To observe whether the patient started fertility treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to fertility treatment initiation | This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment. | To observe the interval between study enrollment and start fertility treatment, if any. |
Countries
United States
Contacts
CONTACTAmber Mendoza
Outcome results
None listed