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NCT Number: NCT07083700

Frame Support 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.

Recruiting

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Key information

Conditions

Fertility Issues Behavior Behavioral Symptoms Emotional Stress Genital Diseases Infertility Stress, Psychological Urogenital Diseases

Age range

22 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inception Fertility Research Institute

Houston, Texas, 77081, United States

Location status: Recruiting

Location contact

Amber Mendoza

CONTACT

[email protected]

3463932265

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Mendoza

CONTACT

[email protected]

346-393-2265

Sponsors and collaborators

Lead sponsor

Inception Fertility Research Institute, LLC

Industry

Collaborators

  • Reframe Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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