NCT06636838

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

September 30, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

Spanish speakingSpanishinfertilityInfertility work-upIVF

Outcome Measures

Primary Outcomes (1)

  • Completion of diagnostic tests

    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 Outcomes (1)

  • Patient satisfaction and communication

    90 days from initial consultation.

Study Arms (2)

Spanish speaking patients seen by English-Speaking Provider

NO INTERVENTION

Spanish speaking patients will be seen by our English-speaking providers using a qualified interpreter.

Spanish-Speaking patients seen by a Spanish-speaking provider

EXPERIMENTAL

Spanish speaking patients will be seen by our Spanish-speaking provider

Behavioral: Spanish-Speaking Provider

Interventions

Spanish speaking patients will be seen by our Spanish-speaking provider

Spanish-Speaking patients seen by a Spanish-speaking provider

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63108, United States

RECRUITING

Related Publications (3)

  • Jain M, Peterson A, Nguyen N, Goldsammler M. Reproductive inequity and inferior intrauterine insemination outcomes in patients with limited English proficiency: a retrospective cohort study. Fertil Steril. 2023 Oct;120(4):844-849. doi: 10.1016/j.fertnstert.2023.05.154. Epub 2023 May 22.

    PMID: 37225071BACKGROUND
  • Lopez Vera A, Thomas K, Trinh C, Nausheen F. A Case Study of the Impact of Language Concordance on Patient Care, Satisfaction, and Comfort with Sharing Sensitive Information During Medical Care. J Immigr Minor Health. 2023 Dec;25(6):1261-1269. doi: 10.1007/s10903-023-01463-8. Epub 2023 Feb 25.

    PMID: 36840903BACKGROUND
  • Berdahl TA, Kirby JB. Patient-Provider Communication Disparities by Limited English Proficiency (LEP): Trends from the US Medical Expenditure Panel Survey, 2006-2015. J Gen Intern Med. 2019 Aug;34(8):1434-1440. doi: 10.1007/s11606-018-4757-3. Epub 2018 Dec 3.

    PMID: 30511285BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Aileen Portugal, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 15, 2024

Study Start

October 15, 2024

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations