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Active, Not Recruiting

NCT Number: NCT06481319

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 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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Reproductive Endocrinology

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • Patients in whom fertility treatment with their own eggs is not recommended, egg freezing or oncofertility cycles.
  • Non-English speaking

Treatment and study plan

Infertility Patient Navigator

Behavioral

Assistance with infertility evaluation including scheduling appointments

Primary outcomes

  1. Time to complete infertility evaluation

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the electronic medical record (EMR).

  2. Time to start fertility treatments

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the EMR.

  3. Wait time for urology appointments

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the EMR.

  4. Wait time for weight management appointments

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the electronic medical record.

Secondary outcomes

  1. Pregnancy rate

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the EMR by dividing the number of pregnancies by the number of participants.

  2. Time to live birth

    Time frame: 12 months

    This outcome will be assessed by data abstracted from the EMR.

  3. Frequency of PN contacts in Intervention Group

    Time frame: 12 months

    This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group

  4. Number of PN contacts in Intervention Group

    Time frame: 12 months

    This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group

  5. Duration of PN contacts in Intervention Group

    Time frame: 12 months

    This outcome will be assessed from data documented by the PN study records for each participant in the Intervention group

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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