Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06636838

Conditions

Infertility

Infertility (IVF Patients)

Infertility Assisted Reproductive Technology

Ovulation Ind

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spanish-Speaking Provider

Study Details

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).

Conditions

Infertility

Infertility (IVF Patients)

Infertility Assisted Reproductive Technology

Ovulation Ind

Study ID

NCT06636838

Start date

Oct 15, 2024

Status verified date

Mar, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Sep 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

Spanish-Speaking Provider

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

Primary outcome measure

  • Completion of diagnostic tests [ Time Frame: 90 days from initial consultation. ]

Central Contacts and Locations

Central contacts

Locations

Washington University in St Louis

Recruiting

Saint Louis, Missouri, United States, 63108

Contacts

Principal Investigator:

Aileen Portugal, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • Spanish speaking
  • Spanish
  • infertility
  • Infertility work-up
  • IVF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-03-28.