Frame Support Study

Inception Fertility Research Institute, LLC

Status

Enrolling

Conditions

Emotional Stress

Fertility Issues

Treatments

Behavioral: Frame Access

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07083700

IRI-RH-2025-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

Female

Ages

22 to 44 years old

Volunteers

No Healthy Volunteers

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.