Frame Support Study

NCT ID: NCT07083700

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Fertility Issues Emotional Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Frame Access

Group Type EXPERIMENTAL

Frame Access

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reframe Health, Inc.

UNKNOWN

Sponsor Role collaborator

Inception Fertility Research Institute, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inception Fertility Research Institute

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amber Mendoza

Role: CONTACT

346-393-2265

Facility Contacts

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Amber Mendoza

Role: primary

3463932265

Other Identifiers

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IRI-RH-2025-001

Identifier Type: -

Identifier Source: org_study_id

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