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NCT06481319 · ClinicalTrials.gov registry record · NA
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients
A NA study of Infertility, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06481319: Recruiting NA study of Infertility, sponsored by Boston Medical Center.
NCT06481319 is a NA study of Infertility that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 40 participants, below the 7,589-participant average among 74 other Infertility trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06481319, a NA study of Infertility, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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. 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: 1. 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 2. 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 comm
Primary Outcome
This outcome will be assessed by data abstracted from the electronic medical record (EMR).
Conditions Studied
Interventions
- BEHAVIORAL Infertility Patient Navigator
Study Locations (1)
Massachusetts
- Boston Medical Center, Reproductive Endocrinology - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT06481319 shows while recruiting
NCT06481319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 7,589-participant average among 74 other Infertility trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Infertility appearing as the primary indexed condition, and to 1 intervention - of which Infertility Patient Navigator is the first listed.
NCT06481319 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06481319 about?
NCT06481319 is a clinical study titled "Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved Patients". 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 si...
What is the current status of trial NCT06481319?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-02-06. Estimated completion is 2026-05.
What conditions does trial NCT06481319 study?
This clinical trial studies the following conditions: Infertility.
What interventions are being tested in trial NCT06481319?
The interventions under investigation include: Infertility Patient Navigator (BEHAVIORAL).
Who is sponsoring clinical trial NCT06481319?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06481319 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06481319's enrollment target sits among peer trials
40 65th of 74 higher than 8 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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