Frame Support Study

April 13, 2026 updated by: Inception Fertility Research Institute, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertility treatment initiation
Time Frame: 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.
This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to fertility treatment initiation
Time Frame: 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.
This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-8)
Time Frame: From enrollment to six months after enrollment
Patients will complete the Patient Health Questionnaire (PHQ-8) for depression screening at baseline and end of study. Scores of 10 and above suggest the presence of Major Depressive Disorder with higher scores being more severe.
From enrollment to six months after enrollment
Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS)
Time Frame: From enrollment to 6 months after enrollment.
Patients will complete the Copenhagen Multi-Centre Psychosocial Infertility- Fertility Problem Stress Scale (COMPI-FPSS) at baseline and end of study. Lower scores indicate lower stress.
From enrollment to 6 months after enrollment.
Perceived Stress Scale (PSS-10)
Time Frame: From enrollment to 6 months after enrollment.
Patients will complete the Perceived Stress Scale (PSS-10) at baseline and end of study. Scores will be interpreted as 0-13: Low stress; 14-26: Moderate stress; 27-40: High perceived stress.
From enrollment to 6 months after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inception Fertility Research Institute, LLC

Collaborators

Reframe Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 24, 2025

First Submitted That Met QC Criteria

July 16, 2025

First Posted (Actual)

July 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRI-RH-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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