InfertilityNCT06481319
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
A study testing Infertility Patient Navigator in people with Infertility, run by Boston Medical Center at 1 site in United States.
Trial summary
This investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Infertility Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Intervention cases
- A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2024 to January 31, 2025 Controls
- A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2023 to January 31, 2024.
Who cannot join
- Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Medical Center, Reproductive Endocrinology
Boston, Massachusetts, 02118
About this study
This investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population.
The study aims are to:
Read more
- evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and
- ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation.
Participants will be contacted by the PN and provided with a survey instrument that will test their medical literacy. Then the PN will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. These tasks are part of pursuing fertility care at BMC.
Duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have PN services will be utilized as a comparison group.
Regression analyses will be conducted to explore the association between utilization of a PN and pregnancy rates, considering potential confounding factors.
Establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. Strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. By tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.
- Conditions
- Infertility
- Being tested
- Infertility Patient Navigator
- Keywords
- Infertility Patient Navigator (PN), Under-resourced patients, Cycle based testing, Urology appointments, Health Literacy, Boston Medical Center
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infertility Patient NavigatorBehavioural
Assistance with infertility evaluation including scheduling appointments
| Study group | Role | What they receive |
|---|---|---|
| Infertility Patient Navigator Group | Experimental | Participants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation. Receives: Behavioral: Infertility Patient Navigator |
| Historical Comparison Group | No intervention | Age-matched controls selected from the electronic medical record database who received infertility evaluation without PN assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete infertility evaluation
This outcome will be assessed by data abstracted from the electronic medical record (EMR).
Measured: 12 months
Time to start fertility treatments
This outcome will be assessed by data abstracted from the EMR.
Measured: 12 months
Wait time for urology appointments
This outcome will be assessed by data abstracted from the EMR.
Measured: 12 months
Wait time for weight management appointments
This outcome will be assessed by data abstracted from the electronic medical record.
Measured: 12 months
Secondary outcomes (5)
Pregnancy rate
This outcome will be assessed by data abstracted from the EMR by dividing the number of pregnancies by the number of participants.
Measured: 12 months
Time to live birth
This outcome will be assessed by data abstracted from the EMR.
Measured: 12 months
Frequency of PN contacts in Intervention Group
This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Measured: 12 months
Number of PN contacts in Intervention Group
This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Measured: 12 months
Duration of PN contacts in Intervention Group
This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start6 Feb 2025
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
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.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group intervention with age-matched historical controls
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Kuohung, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481319
- Sponsor's protocol ID
- H-44747
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2024
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
- ClinicalTrials.gov ID
- NCT06481319
- Acronym / sponsor ID
- H-44747
- Conditions
- Infertility
- Keywords
- Infertility Patient Navigator (PN), Under-resourced patients, Cycle based testing, Urology appointments, Health Literacy, Boston Medical Center
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 1 Jul 2024 (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 investigators will conduct a pilot study investigating the implementation of an infertility Patient Navigator (PN) program to mitigate challenges for underserved individuals at Boston Medical Center (BMC) seeking infertility care. The primary objective is to assess whether the PN program can significantly reduce time to completion of infertility evaluation and to initiation of fertility treatment (if recommended) for infertile patients from an underserved patient population.
The study aims are to:
- evaluate the impact of the PN program on timelines including obtaining commercial insurance coverage for infertility, expediting labwork/imaging, weight management, and partner urology appointments, and initiating fertility treatment; and
- ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation.
Participants will be contacted by the PN and provided with a survey instrument that will test their medical literacy. Then the PN will assist with scheduling cycle-based testing including labwork and uterine cavity evaluation, the partner's urology appointment, the patient's appointments such weight management/nutrition referral, mammograms (if indicated by age), and insurance counseling if the participant's current insurance does not cover infertility diagnostic testing and treatment. These tasks are part of pursuing fertility care at BMC.
Duration of evaluation and time to treatment in age-matched control patients from the year prior that did not have PN services will be utilized as a comparison group.
Regression analyses will be conducted to explore the association between utilization of a PN and pregnancy rates, considering potential confounding factors.
Establishment of the pilot program will enable the investigators to apply for a larger institutional patient care grant going forward. Strategies developed through this research can may enhance fertility care access for underserved communities across various healthcare settings. By tailoring interventions to populations not usually able to access specialized healthcare services, this study pioneers a paradigm shift towards inclusivity and equity in reproductive medicine.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group intervention with age-matched historical controls
| Arm | Type | Receives |
|---|---|---|
| Infertility Patient Navigator Group | Experimental | Behavioral: Infertility Patient NavigatorParticipants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation. |
| Historical Comparison Group | No intervention | –Age-matched controls selected from the electronic medical record database who received infertility evaluation without PN assistance. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Intervention cases
- A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2024 to January 31, 2025 Controls
- A new patient at BMC Reproductive Endocrinology for the diagnosis of infertility from July 1, 2023 to January 31, 2024.
Key exclusion criteria (2 listed)
- Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
- Non-English speaking
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 |
|---|---|---|
| Infertility Patient NavigatorAssistance with infertility evaluation including scheduling appointments | Behavioural | Infertility Patient Navigator Group |
Primary outcome
Time to complete infertility evaluation
Time frame: 12 months
This outcome will be assessed by data abstracted from the electronic medical record (EMR).
Time to start fertility treatments
Time frame: 12 months
This outcome will be assessed by data abstracted from the EMR.
Wait time for urology appointments
Time frame: 12 months
This outcome will be assessed by data abstracted from the EMR.
Wait time for weight management appointments
Time frame: 12 months
This outcome will be assessed by data abstracted from the electronic medical record.
5 secondary outcomes
Pregnancy rate
Time frame: 12 months
Time to live birth
Time frame: 12 months
Frequency of PN contacts in Intervention Group
Time frame: 12 months
Number of PN contacts in Intervention Group
Time frame: 12 months
Duration of PN contacts in Intervention Group
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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. This study is not recruiting at the moment.
Wendy Kuohung, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infertility Patient Navigator in people with Infertility, run by Boston Medical Center 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 2 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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete infertility evaluation (time frame: 12 months). The study lists 4 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 1 Sep 2026.