Frame Support Study

Purpose

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.

Conditions

  • Fertility Issues
  • Emotional Stress

Eligibility

Eligible Ages
Between 22 Years and 44 Years
Eligible Sex
Female
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control Group
Experimental
Frame Access
  • 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 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.

Recruiting Locations

Inception Fertility Research Institute
Houston, Texas 77081
Contact:
Amber Mendoza
3463932265
amendoza@inceptionllc.com

More Details

Status
Recruiting
Sponsor
Inception Fertility Research Institute, LLC

Study Contact

Amber Mendoza
346-393-2265
amendoza@inceptionllc.com

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.