Language Matters: Exploring the Impact of Language Concordance on Fertility Treatment Progression (ImpaLa)

March 24, 2025 updated by: Washington University School of Medicine

Currently, patients presenting to the Fertility and Reproductive Medicine Center meet with an English-speaking provider and communicate through an interpreter, as none of the physicians speak Spanish. However, this study PI is a native Spanish speaker and certified bilingual clinician. Thus, this study is looking to evaluate whether or not the use of an interpreter delays completion of testing and initiation of fertility treatment. The medically indicated testing, procedures, and course of treatment will not be altered as a result of participation in the study. Participants will be asked to complete a survey in their preferred language to gauge satisfaction and communication efficacy.

This proposed study is significant as it seeks to address a critical gap in the understanding of how language concordance between healthcare providers and patients influences treatment outcomes in fertility care. With Spanish being the most commonly spoken non-English language in the U.S., evaluating the impact of Spanish language skills in medical care is both timely and essential. This research will shed light on whether Spanish-speaking patients experience better treatment progression and outcomes when cared for by language-concordant providers versus when interpreters are used in fertility care.

This prospective study will be conducted at Washington University's Fertility and Reproductive Medicine Center over a 12-month period. The investigators aim to enroll a total of 70 Spanish-speaking patients, based on previous patient trends at the Center 35 will be randomized to the intervention group (being evaluated and treated by a Spanish-speaking provider), and 35 will be randomized to standard of care (communicating with an English-speaking provider through an interpreter).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University in St Louis
        • Contact:
        • Principal Investigator:
          • Aileen Portugal, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be greater than 18 years old
  • Preferred language must be Spanish speaking
  • Must be seeking fertility treatment

Exclusion Criteria:

  • Preferred language English
  • Not currently seeking fertility care
  • Less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Spanish speaking patients seen by English-Speaking Provider
Spanish speaking patients will be seen by our English-speaking providers using a qualified interpreter.
Experimental: Spanish-Speaking patients seen by a Spanish-speaking provider
Spanish speaking patients will be seen by our Spanish-speaking provider
Behavioral: Spanish-Speaking Provider
Spanish speaking patients will be seen by our Spanish-speaking provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of diagnostic tests
Time Frame: 90 days from initial consultation.
The primary outcome is the time from the patients initial consultation to the completion of the recommended fertility diagnostic tests such as blood work or a pelvic ultrasound. Given that the tests are typically specific to the menstrual cycle, the investigators want know if the patients are completing their work-up faster when they see a Spanish-speaking physician thus understanding the instructions versus when the English speaking providers use an interpreter. The work-up only includes the labs and imaging that was recommended during their initial visit. The outcome will be measured by the unit - days.
90 days from initial consultation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction and communication
Time Frame: 90 days from initial consultation.
Patient satisfaction and communication effectiveness, assessed through surveys administered after the initial consultation. The survey is a validated survey that uses a point system metric to conclude patient satisfaction similar to the PHQ-9 survey.
90 days from initial consultation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB ID #: 202407176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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