Fertility IssuesNCT07083700
Frame Support Study
A study testing Frame Access in people with Fertility Issues and Emotional Stress, run by Inception Fertility Research Institute, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 44 years, women only
- Conditions the study is for
- Fertility Issues, Emotional Stress
- What is being tested?
- Frame Access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inception Fertility Research Institute
Houston, Texas, 77081
Amber Mendoza, 3463932265, amendoza@inceptionllc.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fertility Issues, Emotional Stress
- Being tested
- Frame Access
- Medical subject headings
- Infertility, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frame AccessBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Frame Access | Experimental | Not described Receives: Behavioral: Frame Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility treatment initiation
To observe whether the patient started fertility treatment.
Measured: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
Secondary outcomes (1)
Time to fertility treatment initiation
To observe the interval between study enrollment and start fertility treatment, if any.
Measured: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start23 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reframe Health, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083700
- Sponsor's protocol ID
- IRI-RH-2025-001
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Frame™ Platform on Infertility Patient Retention and Emotional Health: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07083700
- Acronym / sponsor ID
- IRI-RH-2025-001
- Conditions
- Fertility Issues, Emotional Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Reframe Health, Inc.
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Frame Access | Experimental | Behavioral: Frame Access |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frame AccessFRAME™ 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. | Behavioural | Frame Access |
Primary outcome
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.
1 secondary outcome
Time to fertility treatment initiation
Time frame: This will be evaluated at the end of patient's study participation, approximately 6 months post enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frame Access in people with Fertility Issues and Emotional Stress, run by Inception Fertility Research Institute, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Mendoza (346-393-2265, amendoza@inceptionllc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.