Frame Support Study

Part of paid clinical trials in Houston, Texas.

Sponsor
Inception Fertility Research Institute, LLC
Study ID
NCT07083700
Status
Recruiting
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Conditions

  • Emotional Stress
  • Fertility Issues

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 44 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control Group
  • Experimental: Frame Access

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Inception Fertility Research InstituteHoustonTexas77081
Amber Mendoza
[email protected]
3463932265

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