Recruiting

Observational Study

Sponsor:

Inception Fertility Research Institute, LLC

Code:

NCT07083700

Conditions

Fertility Issues

Emotional Stress

Eligibility Criteria

Sex: Female

Age: 22 - 44

Healthy Volunteers: Not accepted

Interventions

Frame Access

Study Details

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

Study ID

NCT07083700

Start date

Jun 23, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 44

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control Group

experimental: Frame Access

Interventions

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.

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 and Locations

Central contacts

Amber Mendoza

346-393-2265amendoza@inceptionllc.com

Locations

Inception Fertility Research Institute

Recruiting

Houston, Texas, United States, 77081

Contacts

Amber Mendoza

3463932265amendoza@inceptionllc.com

More Information

Sponsor

Inception Fertility Research Institute, LLC

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Inception Fertility Research Institute, LLC on 2026-04-15.