NCT06481319

Brief 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. 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. 2.ascertain the medical literacy of participants with a validated tool to assess the impact of low medical literacy on PN facilitation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

February 6, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

June 25, 2024

Last Update Submit

February 17, 2026

Conditions

Infertility

Keywords

Infertility Patient Navigator (PN)Under-resourced patientsCycle based testingUrology appointmentsHealth LiteracyBoston Medical Center

Outcome Measures

Primary Outcomes (4)

  • Time to complete infertility evaluation

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

    12 months

  • Time to start fertility treatments

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

    12 months

  • Wait time for urology appointments

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

    12 months

  • Wait time for weight management appointments

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

    12 months

Secondary Outcomes (5)

  • Pregnancy rate

    12 months

  • Time to live birth

    12 months

  • Frequency of PN contacts in Intervention Group

    12 months

  • Number of PN contacts in Intervention Group

    12 months

  • Duration of PN contacts in Intervention Group

    12 months

Study Arms (2)

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.

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.

Interventions

Infertility Patient NavigatorBEHAVIORAL

Assistance with infertility evaluation including scheduling appointments

Infertility Patient Navigator Group

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center, Reproductive Endocrinology

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Wendy Kuohung, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Kuohung, MD

CONTACT

617-414-5175wkuohung@bu.edu

Nora Khalil, BS

CONTACT

617-414-5175nokhalil@bu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: One group intervention with age-matched historical controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

February 6, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)