Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 43 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
One group intervention with age-matched historical controls
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Infertility Patient Navigator Group
Participants in this group will receive assistance from the Infertility Patient Navigator (PN) to schedule and complete the infertility evaluation.
  • Behavioral: Infertility Patient Navigator
    Assistance with infertility evaluation including scheduling appointments
No Intervention
Historical Comparison Group
Age-matched controls selected from the electronic medical record database who received infertility evaluation without PN assistance.

Recruiting Locations

Boston Medical Center, Reproductive Endocrinology
Boston, Massachusetts 02118
Contact:
Wendy Kuohung, MD
wkuohung@bu.edu

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Wendy Kuohung, MD
617-414-5175
wkuohung@bu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.