NCT07083700

Frame Support Study

The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Inception Fertility Research Institute, LLC · Industry
• Sex: Female
• Age: 22 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fertility Issues
• Emotional Stress

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-23
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-07-24
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States