Frame Support Study

NCT07083700 | Recruiting

• 1 other identifier: IRI-RH-2025-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Issues; Emotional Stress

Outcome Measures

Primary Outcomes (1)

• Fertility treatment initiation

  To observe whether the patient started fertility treatment.

  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

  This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.

Other Outcomes (3)

• Patient Health Questionnaire (PHQ-8)

  From enrollment to six months after enrollment

• Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS)

  From enrollment to 6 months after enrollment.

• Perceived Stress Scale (PSS-10)

  From enrollment to 6 months after enrollment.

Study Arms (2)

Control Group

NO INTERVENTION

Frame Access

EXPERIMENTAL

Behavioral: Frame Access

Interventions

Frame Access BEHAVIORAL

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.

Frame Access

Eligibility Criteria

• Age: 22 Years - 44 Years
• Gender Eligibility Details: This research is targeting patients who are the primary recipient of fertility treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inception Fertility Research Institute, LLC: lead
• Reframe Health, Inc.: collaborator

Study Sites (1)

Inception Fertility Research Institute

Houston, Texas, 77081, United States

RECRUITING

MeSH Terms

Conditions

Infertility; Stress, Psychological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Amber Mendoza

CONTACT

346-393-2265; amendoza@inceptionllc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 24, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)