InfertilityPEPNCT07725458
Patient Empowerment Project (PEP) Study
An observational study of Infertility and Mental Health, run by Inception Fertility Research Institute, LLC at 2 sites in United States.
Trial summary
The Patient Empowerment Project (PEP) will be integrated into the intake process at a fertility clinic to prepare clinical staff for any patient sensitivities or preferences and provide extra support if needed. The study will evaluate if the PEP increases patient retention and patient satisfaction scores. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility, Mental Health
- What is being tested?
- Patient Empowerment Program (PEP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Aug 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients seeking fertility treatment at participating clinics
Patients seeking fertility treatment at participating clinics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Aspire Fertility Dallas
Dallas, Texas, 75247
The Reproductive Medicine Group
Tampa, Florida, 33609
Laurel Anderson, BS, 3463621476, landerson@inceptionllc.com
About this study
Official title: Efficacy of an Infertility Patient Empowerment Project (PEP), a Pilot Study
The Patient Empowerment Project (PEP) will be integrated into the intake process at a fertility clinic to prepare clinical staff for any patient sensitivities or preferences and provide extra support if needed. The study will evaluate if the PEP increases patient retention and patient satisfaction scores.
- Conditions
- Infertility, Mental Health
- Being tested
- Patient Empowerment Program (PEP)
- Keywords
- Infertility, Mental health, Assistive Reproductive Technology
- Medical subject headings
- Infertility, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Empowerment Program (PEP)Behavioural
The clinic staff will receive PEP training from a licensed psychologist (the PI). PEP will be implemented, starting after training is complete. The PEP Introduction and the PEP Questionnaire will be included in the New Patient Packet. The patient will complete the PEP questionnaire as they complete their new patient intake forms. Clinic staff will tailor their approach to the patient based on the patient's responses to the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The PEP questionnaire will be implemented at the intervention clinic and staff will receive training to address responses. Receives: Behavioral: Patient Empowerment Program (PEP) | |
| Control | Patients at the Control clinic will receive standard of care with no changes or additional questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Standard patient satisfaction surveys will be collected at regular intervals throughout the study period
Measured: New Patient consultation to 6 months later
Patient Retention Rate
Patient retention is measured by the percentage of patients who attended a new patient consult and moved forward with treatment.
Measured: New patient consultation to 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inception Fertility Research Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725458
- Sponsor's protocol ID
- IRI-PEP-2026-003
- Acronym
- PEP
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Infertility Patient Empowerment Project (PEP), a Pilot Study
- ClinicalTrials.gov ID
- NCT07725458
- Acronym / sponsor ID
- PEP / IRI-PEP-2026-003
- Conditions
- Infertility, Mental Health
- Keywords
- Infertility, Mental health, Assistive Reproductive Technology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Inception Fertility Research Institute, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jul 2026 (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.
The Patient Empowerment Project (PEP) will be integrated into the intake process at a fertility clinic to prepare clinical staff for any patient sensitivities or preferences and provide extra support if needed. The study will evaluate if the PEP increases patient retention and patient satisfaction scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Patient Empowerment Program (PEP)The PEP questionnaire will be implemented at the intervention clinic and staff will receive training to address responses. |
| Control | – | –Patients at the Control clinic will receive standard of care with no changes or additional questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking fertility treatment at participating clinics
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 |
|---|---|---|
| Patient Empowerment Program (PEP)The clinic staff will receive PEP training from a licensed psychologist (the PI). PEP will be implemented, starting after training is complete. The PEP Introduction and the PEP Questionnaire will be included in the New Patient Packet. The patient will complete the PEP questionnaire as they complete their new patient intake forms. Clinic staff will tailor their approach to the patient based on the patient's responses to the questionnaire. | Behavioural | Intervention |
Primary outcome
Patient Satisfaction
Time frame: New Patient consultation to 6 months later
Standard patient satisfaction surveys will be collected at regular intervals throughout the study period
Patient Retention Rate
Time frame: New patient consultation to 6 months later
Patient retention is measured by the percentage of patients who attended a new patient consult and moved forward with treatment.
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 27 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Mental Health, run by Inception Fertility Research Institute, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Laurel Anderson, BS (3463621476, landerson@inceptionllc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: New Patient consultation to 6 months later). The study lists 2 primary outcomes in all. 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 27 Jul 2026.